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

NCT06120283 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BGB-43395

Planned doses administered orally.

DRUG

Fulvestrant

Standard dose administered via intramuscular injection.

DRUG

Letrozole

Standard dose administered orally as a tablet.

DRUG

Elacestrant

Standard dose administered orally as a tablet.

DRUG

Anti-Diarrheal Agent

Administered orally as a tablet.

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • China
  • France
  • Japan
  • Malaysia
  • Moldova
  • New Zealand
  • South Korea
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120283 on ClinicalTrials.gov