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History of Changes for Study: NCT05381909
Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors
Latest version (submitted August 19, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 16, 2022 None (earliest Version on record)
2 July 6, 2022 Recruitment Status, Study Status and Contacts/Locations
3 August 19, 2022 Study Status and Contacts/Locations
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Study NCT05381909
Submitted Date:  May 16, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGB-24714-101
Brief Title: Study Investigating BGB-24714 as Monotherapy and in Combination With Chemotherapy in Participants With Advanced or Metastatic Solid Tumors
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Not yet recruiting
Study Start: June 8, 2022
Primary Completion: July 26, 2024 [Anticipated]
Study Completion: January 22, 2025 [Anticipated]
First Submitted: May 16, 2022
First Submitted that
Met QC Criteria:
May 16, 2022
First Posted: May 19, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
May 16, 2022
Last Update Posted: May 19, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BeiGene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Solid Tumor, Adult
Keywords: Solid tumors
Advanced Solid Tumors
Metastatic Solid Tumors
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 244 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.

Open or close this module Contacts/Locations
Central Contact Person: BeiGene
Telephone: 1-877-828-5568
Email: ClinicalTrials@beigene.com
Locations: United States, Florida
Florida Cancer Specialists-Sarasota
Santa Rosa Beach, Florida, United States, 34232
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Australia
Icon Cancer Care- South Brisbane
Queensland, Australia, 4101
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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