A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors

NCT05381909
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Phase
Phase 1
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Recruitment status
Terminated
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Participants
157
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Lead sponsor
BeiGene
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Start date
2022-07-06
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Number of sites
34
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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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Short title
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors
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Official 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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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 1
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Study type
Interventional
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Reason stopped
The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.
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Completion date
2025-07-25
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First posted
2022-05-19
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Registry last updated
2026-02-20
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Primary completion date
2025-07-25
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Start date
2022-07-06
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Actual participants
157
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Participants
157
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
34
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
BeiGene
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05381909
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ClinicalTrials.gov ID
NCT05381909
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Escalation: Number of participants with adverse events (AEs)

    Timeframe: approximately 6 months

    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria.

  2. Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)

    Timeframe: approximately 6 months

  3. Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT)

    Timeframe: approximately 6 months

    Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available

  4. Dose Expansion: Objective response rate (ORR)

    Timeframe: approximately 2 Years

    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)

  1. Dose Escalation: Objective response rate (ORR)

    Timeframe: approximately 2 Years

    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)

  2. Dose Expansion: Progression-free Survival (PFS)

    Timeframe: approximately 2 Years

    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

  3. Dose Expansion: Number of participants with adverse events

    Timeframe: approximately 2 Years

    Number of participants with AEs and SAEs

  4. Duration of Response (DOR)

    Timeframe: approximately 2 Years

    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)

  5. Disease Control Rate (DCR)

    Timeframe: approximately 2 Years

    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)

  6. Clinical Benefit Rate (CBR)

    Timeframe: approximately 2 Years

    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)

  7. Plasma Concentrations of BGB-24714 and its metabolite

    Timeframe: approximately 2 Years

  8. Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  9. Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  10. Terminal Half-life (t1/2) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  11. Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  12. Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  13. Apparent Clearance (CL/F) of BGB-24714

    Timeframe: Up to 48 hours postdose

  14. Apparent Volume Of Distribution (Vz/F) of BGB-24714

    Timeframe: Up to 48 hours postdose

  15. Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  16. Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

  17. 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

    Timeframe: Up to 48 hours postdose

  18. Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite

    Timeframe: Up to 48 hours postdose

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

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.

Sources for eligibility
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  • Banner Md Anderson Cancer CenterGilbert, United States
  • Florida Cancer Specialist (Scri) SarasotaSarasota, United States
  • Scri Florida Cancer Specialists NorthSt. Petersburg, United States
  • Scri Florida Cancer Specialist EastWest Palm Beach, United States
  • Massachusetts General HospitalBoston, United States
  • Barbara Ann Karmanos Cancer InstituteDetroit, United States
  • Hackensack University Medical CenterHackensack, United States
  • Upmc Hillman Cancer Center(Univ of Pittsburgh)Pittsburgh, United States
  • Sanford Cancer CenterSioux Falls, United States
  • Avera Cancer InstituteSioux Falls, United States
  • Tennessee Oncology, Pllc NashvilleNashville, United States
  • Mary Crowley Cancer ResearchDallas, United States
  • University of Texas Southwestern Medical CenterDallas, United States
  • The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology)Houston, United States
  • Intermountain HealthcareSalt Lake City, United States
  • Next VirginiaFairfax, United States
  • University of WashingtonSeattle, United States
  • Northern Beaches HospitalFrenchs Forest, Australia
  • Icon Cancer Centre South BrisbaneSouth Brisbane, Australia
  • Princess Alexandra HospitalWoolloongabba, Australia
  • Austin HealthHeidelberg, Australia
  • Peter Maccallum Cancer CentreMelbourne, Australia
  • Sunshine HospitalSt Albans, Australia
  • Chongqing Cancer HospitalChongqing, China
  • Henan Cancer HospitalZhengzhou, China

And 9 more, listed on the interactive page.

Sources for sites
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Other registry identifiers

  • CTR20232532
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (15)