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Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05381909
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE May 16, 2022
First Posted Date  ICMJE May 19, 2022
Last Update Posted Date August 22, 2022
Actual Study Start Date  ICMJE July 6, 2022
Estimated Primary Completion Date July 26, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Dose Escalation: Number of participants with adverse events (AEs) [ Time Frame: 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.
  • Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy and in combination with chemotherapy [ Time Frame: approximately 6 months ]
    The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate.
  • Dose Escalation: Recommended Phase 2 dose (RP2D) of BGB-24714 as monotherapy and in combination with chemotherapy [ Time Frame: approximately 6 months ]
    Recommended dose based upon the MTD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available
  • Dose Expansion: Objective response rate (ORR) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Dose Escalation: Objective response rate (ORR) [ Time Frame: 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)
  • Dose Expansion: Progression-free Survival (PFS) [ Time Frame: 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
  • Dose Expansion: Number of participants with adverse events [ Time Frame: approximately 2 Years ]
    Number of participants with AEs and SAEs
  • Duration of Response (DOR) [ Time Frame: 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)
  • Disease Control Rate (DCR) [ Time Frame: 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)
  • Plasma concentration of BGB-24714 [ Time Frame: approximately 2 Years ]
  • Plasma Concentrations of BGB-24714 metabolite [ Time Frame: approximately 2 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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 in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors
Brief Summary This is an open-label, multicenter, and non-randomized Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-24714 as monotherapy and in combination with chemotherapy in participants with advanced or metastatic solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE
  • Drug: BGB-24714
    administered orally
  • Drug: Paclitaxel
    administered intravenously
Study Arms  ICMJE
  • Experimental: Phase 1a: Dose Escalation Part A
    Participants will receive escalating doses of BGB-24714 as monotherapy
    Intervention: Drug: BGB-24714
  • Experimental: Phase 1a: Dose Escalation Part B
    Participants will receive increasing dose levels of BGB-24714 in combination with chemotherapy
    Interventions:
    • Drug: BGB-24714
    • Drug: Paclitaxel
  • Experimental: Phase 1b: (Dose Expansion)
    Participants will receive the recommended phase 2 dose (RP2D) of BGB-24714 monotherapy or in combination with chemotherapy as determined from Phase 1a
    Interventions:
    • Drug: BGB-24714
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2022)
244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 22, 2025
Estimated Primary Completion Date July 26, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Eligibility Criteria:

  1. Patient must sign a written informed consent form (ICF); and agree to comply with study requirement.
  2. Phase 1a (Dose Escalation): Patients 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.
  3. Patients must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample. If archival tissue is not available, fresh tumor biopsy is mandatory.
  4. ≥ 1 measurable lesion per RECIST v1.1
  5. ECOG Performance Status ≤ 1
  6. Patient with adequate organ function

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. Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
  6. Prior exposure to agents with Smac mimetics, or other IAP antagonists.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1-877-828-5568 ClinicalTrials@beigene.com
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05381909
Other Study ID Numbers  ICMJE BGB-24714-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP