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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05904496
Registration number
NCT05904496
Ethics application status
Date submitted
6/06/2023
Date registered
15/06/2023
Date last updated
20/08/2024
Titles & IDs
Public title
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
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Scientific title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the DGK? Inhibitor BGB-30813, Alone or in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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U1111-1290-6118
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Secondary ID [2]
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BGB-A317-30813-101
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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:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-30813
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy -
Experimental: Phase 1a: Dose Escalation Part B: BGB-30813 + Tislelizumab -
Experimental: Phase 1b: Dose Expansion BGB-30813 in Combination with Tislelizumab -
Treatment: Drugs: BGB-30813
Specified dose administered on specified days
Treatment: Drugs: Tislelizumab
Specified dose administered on specified days
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Intervention code [1]
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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 1a: Dose Escalation: Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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Number of participants experiencing AEs and SAEs, including physical examination findings, electrocardiograms (ECGs), and lab assessments as needed; and AEs meeting protocol-defined DLT criteria.
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Timepoint [1]
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Up to Approximately 23 months
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Primary outcome [2]
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Phase 1a: Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD)
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Assessment method [2]
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The MTD or MAD is defined as the highest dose at which 30% of participants experience a DLT or the highest dose administered, respectively.
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Timepoint [2]
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Up to approximately 23 months
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Primary outcome [3]
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Phase 1a and 1b: Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
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Assessment method [3]
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The RDFE(s) of BGB-30813 alone or in combination with tislelizumab, determined based upon the MTD or MAD and other relevant data.
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Timepoint [3]
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Up to approximately 23 months
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Primary outcome [4]
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Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
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Assessment method [4]
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ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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Timepoint [4]
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Up to approximately 2 years and 11 months
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Secondary outcome [1]
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Phase 1a: Dose Escalation: ORR as Determined by the Investigator
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Assessment method [1]
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ORR is defined as the percentage of participants who had confirmed CR or PR as determined from tumor assessments by the investigator per RECIST version 1.1
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Timepoint [1]
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Up to approximately 23 months
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Secondary outcome [2]
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Phase 1a: Dose Escalation: Maximum Observed Plasma Concentration (Cmax) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
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Assessment method [2]
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Timepoint [2]
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From Cycle 1 Day 1 up to Cycle 9 Day 1
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Secondary outcome [3]
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Phase 1a: Dose Escalation: Observed Plasma Trough Concentration (Ctrough) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
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Assessment method [3]
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Timepoint [3]
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From Cycle 1 Day 1 up to Cycle 9 Day 1
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Secondary outcome [4]
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Phase 1a: Dose Escalation: Area under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
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Assessment method [4]
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Timepoint [4]
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From Cycle 1 Day 1 up to Cycle 9 Day 1
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Secondary outcome [5]
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Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
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Assessment method [5]
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Timepoint [5]
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From Cycle 1 Day 1 up to Cycle 9 Day 1
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Secondary outcome [6]
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Phase 1b: Dose Expansion: Number of Participants Experiencing AEs and SAEs
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Assessment method [6]
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Number of participants experiencing AEs and SAEs, including physical examination findings, ECGs, and lab assessments as needed.
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Timepoint [6]
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Up to approximately 2 years and 11 months
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Secondary outcome [7]
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Phase 1b: Dose Expansion: Duration of Response (DOR)
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Assessment method [7]
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DOR is defined as the time from the first determination of an overall response assessed by the investigator using RECIST v1.1, until the first documentation of disease progression or death, whichever comes first.
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Timepoint [7]
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Up to approximately 2 years and 11 months
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Secondary outcome [8]
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Phase 1b: Dose Expansion: Disease Control Rate (DCR)
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Assessment method [8]
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DCR is defined as the percentage of participants with best overall response (BOR) of complete Response (CR), Partial Response (PR), or stable disease assessed by the investigator using RECIST v1.1.
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Timepoint [8]
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Up to approximately 2 years and 11 months
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Secondary outcome [9]
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Phase 1b: Dose Expansion: Progression Free Survival (PFS)
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Assessment method [9]
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PFS is defined as the time from the date of the first dose of study drugs to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
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Timepoint [9]
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Up to approximately 2 years and 11 months
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Secondary outcome [10]
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Phase 1b: Dose Expansion: Clinical Benefit Rate (CBR)
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Assessment method [10]
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CBR is defined as the percentage of participants with BOR of confirmed CR, PR, or stable disease lasting = 24 weeks as assessed by the investigator using RECIST v1.1.
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Timepoint [10]
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Up to approximately 2 years and 11 months
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Secondary outcome [11]
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Phase 1b: Dose Expansion: Plasma concentrations of BGB-30813, and its metabolite, BGB-33481
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Assessment method [11]
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Timepoint [11]
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Up to approximately 2 years and 11 months
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Eligibility
Key inclusion criteria
* Phase 1a (Dose Escalation):
* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting diacylglycerol kinase (DGK)
* Eligible tumor types are immune sensitive solid tumors such as NSCLC, HNSCC, small cell lung cancer, hepatocellular carcinoma, esophageal cancer, gastric or gastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breast cancer, urothelial carcinoma, renal cell carcinoma, cervical cancer, endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutation burden (TMB)-high, or mismatch repair deficient solid tumors
* Prior checkpoint inhibitor (CPI) therapy is allowed
* Phase 1b (Dose Expansion):
* Participants with selected advanced or metastatic solid tumors including NSCLC, HNSCC, and additional potential tumor types to be defined based on emerging data
* = 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score = 1
* Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
* Adequate organ function as indicated by the following laboratory values up to first dose of study treatment: Hemoglobin= 90 grams per liter (g/L), Absolute neutrophil count = 1.5 x 109/L , Serum total bilirubin = 1.5 x upper limit of normal (ULN) (< 3 x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
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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
* Previous therapy targeting DGK
* Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS) metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any active malignancy = 2 years before the first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
* Systemic anticancer therapy, including chemotherapy = 21 days or 5 half-lives (whichever is shorter) before the first dose of study drugs
* = Grade 3 immune-mediated adverse events on prior immuno-oncology agent (anti-PD-1 or anti-CTLA4 antibodies or other experimental drugs)
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Active, not 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
19/07/2023
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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
1/05/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Monash Health - Clayton
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Recruitment hospital [2]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Spain
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State/province [3]
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Barcelona
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Country [4]
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Spain
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State/province [4]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a First in Human (FIH) Phase 1, multicenter, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-30813 as monotherapy or in combination with tislelizumab in participants with advanced or metastatic solid tumors. The study will be conducted in 2 parts: Phase 1a dose escalation and Phase 1b dose expansion.
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Trial website
https://clinicaltrials.gov/study/NCT05904496
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Director
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Address
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Country
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Phone
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1-877-828-5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT05904496
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