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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05381909
Registration number
NCT05381909
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Titles & IDs
Public title
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
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Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of Second Mitochondrial-derived Activator of Caspases Mimetic BGB-24714 as Monotherapy and With Combination Therapies in Patients With Solid Tumors
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Secondary ID [1]
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CTR20232532
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Secondary ID [2]
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BGB-24714-101
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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:
Solid Tumor, Adult
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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-24714
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Docetaxel
Experimental: Phase 1a: Dose Escalation Part A - Participants will receive escalating doses of BGB-24714 as monotherapy
Experimental: Phase 1a: Dose Escalation Part B - Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel
Experimental: Phase 1a: Dose Escalation Part C - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation
Experimental: Phase 1a: Dose Escalation Part D - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation
Experimental: Phase 1a: Dose Escalation Part A-CN - Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants
Experimental: Phase 1a: Dose Escalation Part E - Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants
Experimental: Phase 1b: Dose Expansion - BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors.
Treatment: Drugs: BGB-24714
administered orally
Treatment: Drugs: Paclitaxel
administered intravenously
Treatment: Drugs: Carboplatin
administered intravenously
Treatment: Drugs: Docetaxel
administered intravenously
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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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Dose Escalation: Number of participants with adverse events (AEs)
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Assessment method [1]
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Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.
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Timepoint [1]
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approximately 6 months
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Primary outcome [2]
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Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
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Assessment method [2]
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Timepoint [2]
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approximately 6 months
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Primary outcome [3]
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Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)
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Assessment method [3]
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Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
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Timepoint [3]
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approximately 6 months
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Primary outcome [4]
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Dose Expansion: Objective response rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [4]
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approximately 2 Years
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Secondary outcome [1]
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Dose Escalation: Objective response rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [1]
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approximately 2 Years
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Secondary outcome [2]
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Dose Expansion: Progression-free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of disease progression as determined by the investigator using RECIST v1.1 or death, whichever occurs first
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Timepoint [2]
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approximately 2 Years
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Secondary outcome [3]
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Dose Expansion: Number of participants with adverse events
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Assessment method [3]
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Number of participants with AEs and SAEs
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Timepoint [3]
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approximately 2 Years
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [4]
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approximately 2 Years
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [5]
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approximately 2 Years
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Secondary outcome [6]
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Clinical Benefit Rate (CBR)
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Assessment method [6]
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CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Timepoint [6]
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approximately 2 Years
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Secondary outcome [7]
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Plasma Concentrations of BGB-24714 and its metabolite
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Assessment method [7]
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Timepoint [7]
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approximately 2 Years
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Secondary outcome [8]
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Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite
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Assessment method [8]
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Timepoint [8]
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Up to 48 hours postdose
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Secondary outcome [9]
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Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite
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Assessment method [9]
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Timepoint [9]
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Up to 48 hours postdose
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Secondary outcome [10]
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Terminal Half-life (t1/2) of BGB-24714 and its metabolite
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Assessment method [10]
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Timepoint [10]
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Up to 48 hours postdose
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Secondary outcome [11]
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Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite
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Assessment method [11]
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Timepoint [11]
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Up to 48 hours postdose
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Secondary outcome [12]
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Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite
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Assessment method [12]
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Timepoint [12]
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Up to 48 hours postdose
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Secondary outcome [13]
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Apparent Clearance (CL/F) of BGB-24714
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Assessment method [13]
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Timepoint [13]
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Up to 48 hours postdose
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Secondary outcome [14]
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Apparent Volume Of Distribution (Vz/F) of BGB-24714
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Assessment method [14]
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Timepoint [14]
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Up to 48 hours postdose
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Secondary outcome [15]
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Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite
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Assessment method [15]
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Timepoint [15]
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Up to 48 hours postdose
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Secondary outcome [16]
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Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite
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Assessment method [16]
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Timepoint [16]
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Up to 48 hours postdose
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Secondary outcome [17]
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Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration at Steady State (AUClast,ss) of BGB-24714 and its metabolite
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Assessment method [17]
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Timepoint [17]
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Up to 48 hours postdose
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Secondary outcome [18]
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Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite
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Assessment method [18]
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Timepoint [18]
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Up to 48 hours postdose
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Eligibility
Key inclusion criteria
Key Eligibility Criteria :
1. Participants must sign a written informed consent form (ICF); and agree to comply with study requirement
2. Phase 1a (Dose Escalation):
Part A, A-CN, and B: Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated Note: Only Chinese participants will be eligible for Part A-CN.
Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT)
Part D: Participant with locally advanced, histologically confirmed inoperable esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT
Phase 1b (Dose Expansion): Participants with histologically or cytologically confirmed solid tumors of selected types previously treated with standard therapy.
3. Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
4. Phase 1a Part A, A-CN, B and Phase 1b: = 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
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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
1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Any malignancy = 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
3. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication = 14 days before the first dose of study drug(s).
4. Clinically significant infection requiring systemic therapy = 14 days before the first dose of study drug(s).
5. Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.
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
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
6/07/2022
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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
1/11/2026
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Actual
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Sample size
Target
210
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Icon Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Recruitment hospital [4]
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Sunshine Hospital - St Albans
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3021 - St Albans
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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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Arizona
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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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Florida
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
0
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
0
0
United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
0
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United States of America
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State/province [7]
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Virginia
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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China
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State/province [9]
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Chongqing
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Country [10]
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China
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State/province [10]
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Henan
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Country [11]
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China
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State/province [11]
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Hunan
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Country [12]
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China
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State/province [12]
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Shandong
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Country [13]
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Korea, Republic of
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State/province [13]
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Gyeonggi-do
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Country [14]
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Korea, Republic of
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State/province [14]
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Incheon Gwang'yeogsi
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Country [15]
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Korea, Republic of
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State/province [15]
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Seoul Teugbyeolsi
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Country [16]
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New Zealand
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State/province [16]
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Auckland
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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 study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.
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Trial website
https://clinicaltrials.gov/study/NCT05381909
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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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BeiGene
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT05381909