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

Last updated: March 21, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Neoplasms

Cancer

Treatment

Fulvestrant

BGB-43395

Letrozole

Clinical Study ID

NCT06253195
BGB-43395-102
CTR20240674
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phase 1a (Dose Escalation): Participants with histologically or cytologicallyconfirmed locally advanced or metastatic solid tumors associated with CDK4dependency, including HR+/HER2- breast cancer. Participants must have received priorstandard-of-care therapies for their disease, unless the therapy is not available ornot tolerated, or is determined not appropriate based on the investigator'sjudgment.

  • Phase 1b (Dose Expansion): Participants with selected solid tumors including locallyadvanced or metastatic HR+/HER2- breast cancer.

  • Female participants with metastatic HR+/HER2- breast cancer will be required to haveovarian function suppression using gonadotropin-releasing hormone (GnRH) agonistssuch as goserelin or be postmenopausal.

  • Male participants with HR+/HER2- breast cancer will be required to have gonadalsuppression 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

Exclusion Criteria:

  • Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy ispermitted).

  • Known leptomeningeal disease or uncontrolled untreated brain metastasis.

  • Any malignancy ≤ 3 years before the first dose of study drug(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

  • Uncontrolled diabetes.

  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28days before the first dose of study drug(s), or symptomatic COVID-19 infection.Patients receiving prophylactic antibiotics (eg, for prevention of urinary tractinfection, chronic obstructive pulmonary disease, or for dental extraction) areeligible. Patients who have recovered from symptomatic COVID-19 infection can berescreened for this study.

  • Untreated chronic hepatitis B or active hepatitis C infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: Fulvestrant
Phase: 1
Study Start date:
April 01, 2024
Estimated Completion Date:
October 26, 2026

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510245
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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