BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
BeOne Medicines
Study ID
NCT06756932
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-21447 — DRUG
    Administered orally.
  • Fulvestrant — DRUG
    Administered via intramuscular injection.
  • BGB-43395 — DRUG
    Administered orally.

Study Details

This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.

Key Dates

Start date
Feb 4, 2025
Status verified
Nov 2025
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: BGB-21447 + Fulvestrant
    Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.
  • Experimental: Part 1B: BGB-21447 + BGB-43395 + Fulvestrant
    Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.
  • Experimental: BGB-21447 + Fulvestrant Food Effect Substudy
    Participants will receive BGB-21447 at the recommended dose with a high-fat meal and under a fasted state in combination with fulvestrant.
  • Experimental: Part 2: Dose Expansion, BGB-21447 + Fulvestrant
    Participants will receive BGB-21447 at the recommended dose(s) for expansion determined in Part 1A in combination with fulvestrant.

Primary Outcome Measure

Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242-1009-
Md Anderson Cancer CenterHoustonTexas77030-3907-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-

Find similar trials in Iowa City, IA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Iowa Hospitals and Clinics· Iowa City, IAMd Anderson Cancer Center· Houston, TXFred Hutchinson Cancer Research Center· Seattle, WA

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