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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

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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: BGB-24714 Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 in Combination With Chemotherapy in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : July 26, 2024
Estimated Study Completion Date : January 22, 2025

Arm Intervention/treatment
Experimental: Phase 1a: Dose Escalation Part A
Participants will receive escalating doses of BGB-24714 as monotherapy
Drug: BGB-24714
administered orally

Experimental: Phase 1a: Dose Escalation Part B
Participants will receive increasing dose levels of BGB-24714 in combination with chemotherapy
Drug: BGB-24714
administered orally

Drug: Paclitaxel
administered intravenously

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
Drug: BGB-24714
administered orally

Drug: Paclitaxel
administered intravenously




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Dose Expansion: Number of participants with adverse events [ Time Frame: approximately 2 Years ]
    Number of participants with AEs and SAEs

  4. 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)

  5. 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)

  6. Plasma concentration of BGB-24714 [ Time Frame: approximately 2 Years ]
  7. Plasma Concentrations of BGB-24714 metabolite [ Time Frame: approximately 2 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381909


Contacts
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Contact: BeiGene 1-877-828-5568 ClinicalTrials@beigene.com

Locations
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United States, Florida
Florida Cancer Specialists-Sarasota Recruiting
Santa Rosa Beach, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Australia
Icon Cancer Care- South Brisbane Recruiting
Queensland, Australia, 4101
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Sponsors and Collaborators
BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05381909    
Other Study ID Numbers: BGB-24714-101
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Solid tumors
Advanced Solid Tumors
Metastatic Solid Tumors
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action