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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05150691
Registration number
NCT05150691
Ethics application status
Date submitted
11/11/2021
Date registered
9/12/2021
Titles & IDs
Public title
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
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Scientific title
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors
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Secondary ID [1]
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DB-1303-O-1001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2-positive Advanced Solid Tumor
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - DB-1303/BNT323
Treatment: Drugs - Pertuzumab Injection
Treatment: Drugs - Ritonavir
Treatment: Drugs - Itraconazole
Experimental: DB-1303/BNT323 Dose Level 1 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 2 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 3 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 4 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 5 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 1 - Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 2 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 3 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 4 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 5 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 6 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Level 7 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 6 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 7 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 8 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 9 - Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 10 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential
Experimental: DB-1303/BNT323 Dose Expansion 11 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 12 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 13 - Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Experimental: DB-1303/BNT323 Dose Expansion 14 - China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment: Other: DB-1303/BNT323
Administered IV
Treatment: Drugs: Pertuzumab Injection
Administered IV
Treatment: Drugs: Ritonavir
Administered oral
Treatment: Drugs: Itraconazole
Administered oral
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.
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Assessment method [1]
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Percentage of participants in Part 1 with DLTs
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Timepoint [1]
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up to 21 days after C1D1
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Primary outcome [2]
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Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
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Assessment method [2]
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Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
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Timepoint [2]
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Up to Safety Follow-Up visit, approximately 35 days post-treatment
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Primary outcome [3]
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Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
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Assessment method [3]
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Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
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Timepoint [3]
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Up to follow-up period, approximately 1 year post-treatment
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Primary outcome [4]
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Phase 1: Maximum Tolerated Dose (MTD) of DB-1303
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Assessment method [4]
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MTD on the data collected during Part 1
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Timepoint [4]
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Up to Safety Follow-Up visit, approximately 35 days post-treatment
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Primary outcome [5]
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Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303
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Assessment method [5]
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RP2D of DB-1303 based on the data collected during Part 1
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Timepoint [5]
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Up to Safety Follow-Up visit, approximately 35 days post-treatment
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Primary outcome [6]
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Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
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Assessment method [6]
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Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
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Timepoint [6]
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Up to follow-up period, approximately 1 year post-treatment
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Primary outcome [7]
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Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
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Assessment method [7]
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Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
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Timepoint [7]
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Up to follow-up period, approximately 1 year post-treatment
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Primary outcome [8]
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Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
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Assessment method [8]
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The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained =4 weeks.
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Timepoint [8]
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Up to follow-up period, approximately 1 year post-treatment
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Primary outcome [9]
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Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors
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Assessment method [9]
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Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)
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Timepoint [9]
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up to safety follow-up visit, approx. 35 days post-treatment
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Primary outcome [10]
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Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.
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Assessment method [10]
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Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)
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Timepoint [10]
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up to safety follow-up visit, approx. 35 days post-treatment
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Secondary outcome [1]
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Phase 1 & Phase 2: Pharmacokinetic-AUC
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Assessment method [1]
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Area under the concentration-time curve from time 0 to infinity of DB-1303
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Timepoint [1]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [2]
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Phase 1 & Phase 2: Pharmacokinetic-Cmax
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Assessment method [2]
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Maximum observed plasma concentration (Cmax) of DB-1303
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Timepoint [2]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [3]
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Phase 1 & Phase 2: Pharmacokinetic-Tmax
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Assessment method [3]
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Time to Cmax of DB-1303
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Timepoint [3]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [4]
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Phase 1 & Phase 2: Pharmacokinetic-T1/2
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Assessment method [4]
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Terminal elimination half-life
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Timepoint [4]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [5]
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Phase 1 & Phase 2: Pharmacokinetic-Ctrough
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Assessment method [5]
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Trough concentration of DB-1303
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Timepoint [5]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [6]
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Phase 1 & Phase 2: Pharmacodynamics-ADA
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Assessment method [6]
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Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.
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Timepoint [6]
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Up to safety follow up visit, approx. 35 days post-treatment
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Secondary outcome [7]
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Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1
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Assessment method [7]
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Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.
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Timepoint [7]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [8]
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Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1
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Assessment method [8]
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The duration of time from date of first CR or PR to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1
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Timepoint [8]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [9]
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Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1
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Assessment method [9]
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The duration of time when receiving the first dose of study drug to the first date that is evaluated as either CR or PR using RECIST V1.1
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Timepoint [9]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [10]
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Phase 2: Time on Therapy
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Assessment method [10]
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The duration of time from participant receiving first dose of study drug to the last dose + 21 days
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Timepoint [10]
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Up to 21 days after the participant's last dose
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Secondary outcome [11]
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Phase 2: Percent change in target lesions as assessed by RECIST 1.1
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Assessment method [11]
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The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1
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Timepoint [11]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [12]
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Phase 1 and 2 Cohort b only: Progression-Free Survival
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Assessment method [12]
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Time from subject receiving the first dose to disease progression or death by any cause
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Timepoint [12]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [13]
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Phase 1 and 2 Cohort b only: Overall Survival
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Assessment method [13]
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Time from subject receiving the first dose to death by any cause
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Timepoint [13]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [14]
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Phase I: Percentage of Objective Response Rate (ORR) as assessed by investigator based on RECIST 1.1
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Assessment method [14]
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The percentage of subjects who had a best response of CR or PR
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Timepoint [14]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [15]
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Phase 2 Cohort b Only: Percentage of ORR as assessed by IRC and as assessed by investigator based on RECIST 1.1 for HER2-expressing subjects and in subjects with prior ICI treatment
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Assessment method [15]
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The percentage of subjects who had a best response of CR or PR, for Cohort 2b only
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Timepoint [15]
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Up to follow-up period, approximately 1 year post-treatment
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Secondary outcome [16]
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To evaluate the safety of DB-1303 with/without ritonavir or itraconazole
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Assessment method [16]
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Percentage of Participants with Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAE), TEAEs \>/= G3, or TEAEs leading to dose reduction, interruption or discontinuation, Adverse Events of Special Interest, (AESIs), abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).
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Timepoint [16]
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Up to follow-up period, approximately 1 year post-treatment
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Eligibility
Key inclusion criteria
* Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* At least 1 measurable lesion (per RECIST 1.1)
* Provide signed informed consent
* ECOG performance status (PS) of 0-1.
* LVEF = 50% by ECHO or MUGA
* Adequate organ functions
* Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
* Life expectancy of = 3 months.
Additional Inclusion Criteria for Part 2 Expansion Group 9:
1. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
* History of myocardial infarction or unstable angina within 6 months before Day 1.
* Average QTcF > 450 ms in males and > 470 ms in females
* History of clinically significant lung diseases
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
* HIV infection with AIDS defining illness or active viral hepatitis.
* Clinically active brain metastases
* Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade = 1 or baseline.
* A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
* Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2027
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Actual
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Sample size
Target
766
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Scientia Clinical Research LTD - Randwick
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Recruitment hospital [2]
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Macquarie Clinical Trials Unit - Sydney
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Recruitment hospital [3]
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Integrated Clinical Oncology Network Pty Ltd (Icon) - South Brisbane
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
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0
District of Columbia
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Country [3]
0
0
United States of America
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State/province [3]
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0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Hawaii
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Country [6]
0
0
United States of America
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State/province [6]
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Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
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0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Missouri
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Nevada
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
North Carolina
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Ohio
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Oklahoma
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Pennsylvania
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Country [17]
0
0
United States of America
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State/province [17]
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Tennessee
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Texas
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Virginia
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Washington
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Country [21]
0
0
China
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State/province [21]
0
0
Anhui
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Country [22]
0
0
China
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State/province [22]
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0
Beijing
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Country [23]
0
0
China
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State/province [23]
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0
Changchun
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Country [24]
0
0
China
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State/province [24]
0
0
Fujian
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Country [25]
0
0
China
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State/province [25]
0
0
Guangdong
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Country [26]
0
0
China
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State/province [26]
0
0
Guangxi
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Country [27]
0
0
China
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State/province [27]
0
0
Hebei
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Country [28]
0
0
China
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State/province [28]
0
0
Hehan
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Country [29]
0
0
China
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State/province [29]
0
0
Henan
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Country [30]
0
0
China
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State/province [30]
0
0
Hubei
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Country [31]
0
0
China
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State/province [31]
0
0
Hunan
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Country [32]
0
0
China
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State/province [32]
0
0
Jiangsu
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0
0
China
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State/province [33]
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0
Jiangxi
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0
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China
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State/province [34]
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Liaoning
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0
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China
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State/province [35]
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Shaanxi
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0
0
China
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State/province [36]
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Shandong
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0
0
China
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State/province [37]
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0
Shangdong
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0
0
China
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State/province [38]
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0
Shanghai
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Country [39]
0
0
China
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State/province [39]
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0
Tianjin
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Country [40]
0
0
China
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State/province [40]
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Yunnan
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0
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China
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State/province [41]
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0
Zhejiang
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Country [42]
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Puerto Rico
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State/province [42]
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Mayaguez
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
DualityBio Inc.
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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BioNTech SE
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
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Trial website
https://clinicaltrials.gov/study/NCT05150691
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Britney Winterberger
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+1-513-403-8568
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05150691