BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Conditions

• Advanced Breast Cancer
• Advanced Solid Tumor
• HER2-negative Breast Cancer
• Hormone Receptor Positive Breast Carcinoma
• Hormone Receptor Positive HER-2 Negative Breast Cancer
• Hormone Receptor Positive Malignant Neoplasm of Breast
• Hormone-receptor-positive Breast Cancer
• Metastatic Breast Cancer
• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BGB-43395 — DRUG
  Planned doses administered orally.
• Fulvestrant — DRUG
  Standard dose administered via intramuscular injection.
• Letrozole — DRUG
  Standard dose administered orally as a tablet.
• Elacestrant — DRUG
  Standard dose administered orally as a tablet.
• Anti-Diarrheal Agent — DRUG
  Administered orally as a tablet.

Study Details

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Key Dates

Start date

Dec 1, 2023

Status verified

May 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

399 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation
  Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant, letrozole, or elacestrant to assess for safety and tolerability.
• Experimental: Safety Expansion
  Phase 1a: Cohorts of selected dose levels of BGB-43395 in combination with fulvestrant or letrozole in HR+/HER2 breast cancer.
• Experimental: Dose Expansion Cohort 1
  Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant) from Phase 1a will be evaluated in HR+ breast cancer.
• Experimental: Dose Expansion Cohort 2
  Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 in combination with letrozole from Phase 1a will be evaluated in HR+ breast cancer.
• Experimental: Dose Expansion Cohort 3
  Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 in combination with letrozole from Phase 1a will be evaluated in HR+ breast cancer. Participants will also receive an anti-diarrheal agent for prophylaxis.

Primary Outcome Measure

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 60 months ]

Central Contacts

• Study Director
  1.877.828.5568
  [email protected]

Locations (10)

Find similar trials in Denver, CO

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