BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

NCT ID: NCT06253195

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-10-26

Brief Summary

This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor; Hormone-receptor-positive Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast; HER2-negative Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a: Dose Escalation

Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole.

Group Type: EXPERIMENTAL

BGB-43395

Intervention Type: DRUG

Administered orally.

Fulvestrant

Intervention Type: DRUG

Administered via intramuscular injection.

Letrozole

Intervention Type: DRUG

Administered orally.

Phase 1b: Dose Expansion

The recommended dose for expansion (RDFE) for BGB-43395 in combination with fulvestrant from Phase 1a will be evaluated in HR+ breast cancer and selected tumor cohorts.

Group Type: EXPERIMENTAL

BGB-43395

Intervention Type: DRUG

Administered orally.

Fulvestrant

Intervention Type: DRUG

Administered via intramuscular injection.

Interventions

BGB-43395

Administered orally.

Intervention Type: DRUG

Fulvestrant

Administered via intramuscular injection.

Intervention Type: DRUG

Letrozole

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors associated with CDK4 dependency, including HR+/HER2- breast cancer. Participants must have received prior standard-of-care therapies for their disease, unless the therapy is not available or not tolerated, or is determined not appropriate based on the investigator's judgment.
• Phase 1b (Dose Expansion): Participants with selected solid tumors including locally advanced or metastatic HR+/HER2- breast cancer.
• Female participants with metastatic HR+/HER2- breast cancer will be required to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists such as goserelin or be postmenopausal.
• Male participants with HR+/HER2- breast cancer will be required to have gonadal suppression using GnRH agonists when being treated with letrozole or fulvestrant.
• Patients must have ≥1 measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
• Adequate organ function without symptomatic visceral disease.

Exclusion Criteria

• Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted).
• Known leptomeningeal disease or uncontrolled untreated brain metastasis.
• 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 (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
• Uncontrolled diabetes.
• Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection. Patients receiving prophylactic antibiotics (eg, for prevention of urinary tract infection, chronic obstructive pulmonary disease, or for dental extraction) are eligible. Patients who have recovered from symptomatic COVID-19 infection can be rescreened for this study.
• Untreated chronic hepatitis B or active hepatitis C infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CTR20240674

Identifier Type: REGISTRY

Identifier Source: secondary_id

BGB-43395-102

Identifier Type: -

Identifier Source: org_study_id