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

Phase 1

Recruiting

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

• Registration Number: NCT06253195
• Lead Sponsor: BeiGene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Inclusion Criteria:<br><br> - Phase 1a (Dose Escalation): Participants with histologically or cytologically<br> confirmed locally advanced or metastatic solid tumors associated with CDK4<br> dependency, including HR+/HER2- breast cancer. Participants must have received prior<br> standard-of-care therapies for their disease, unless the therapy is not available or<br> not tolerated, or is determined not appropriate based on the investigator's<br> judgment.<br><br> - Phase 1b (Dose Expansion): Participants with selected solid tumors including locally<br> advanced or metastatic HR+/HER2- breast cancer.<br><br> - Female participants with metastatic HR+/HER2- breast cancer will be required to have<br> ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists<br> such as goserelin or be postmenopausal.<br><br> - Male participants with HR+/HER2- breast cancer will be required to have gonadal<br> suppression using GnRH agonists when being treated with letrozole or fulvestrant.<br><br> - Patients must have =1 measurable lesion per RECIST v1.1.<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.<br><br> - Adequate organ function without symptomatic visceral disease.<br><br>Exclusion Criteria:<br><br> - Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is<br> permitted).<br><br> - Known leptomeningeal disease or uncontrolled untreated brain metastasis.<br><br> - Any malignancy = 3 years before the first dose of study drug(s) except for the<br> specific cancer under investigation in this study and any locally recurring cancer<br> that has been treated with curative intent (eg, resected basal or squamous cell skin<br> cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).<br><br> - Uncontrolled diabetes.<br><br> - Infection requiring systemic antibacterial, antifungal, or antiviral therapy = 28<br> days before the first dose of study drug(s), or symptomatic COVID-19 infection.<br> Patients receiving prophylactic antibiotics (eg, for prevention of urinary tract<br> infection, chronic obstructive pulmonary disease, or for dental extraction) are<br> eligible. Patients who have recovered from symptomatic COVID-19 infection can be<br> rescreened for this study.<br><br> - Untreated chronic hepatitis B or active hepatitis C infection.<br><br>Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs);Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395;Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395;Phase 1b: Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Phase 1a: ORR;Phase 1b: Progression-Free Survival (PFS);Phase 1b: Number of Participants with AEs and SAEs;Phase 1a and 1b: Duration of Response (DOR);Phase 1a and 1b: Time to Response (TTR);Phase 1b: Disease Control Rate (DCR);Phase 1b: Clinical Benefit Rate (CBR);Phase 1a: Observed plasma maximum concentration (Cmax) of BGB-43395 and its metabolite;Phase 1a: Observed plasma trough concentration (Ctrough) of BGB-43395 and its metabolite;Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite;Phase 1a: Half-life (t1/2) of BGB-43395 and its metabolite;Phase 1b: Plasma concentrations of BGB-43395 and its metabolite