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A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

NCT06257264 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-05-11

No results posted yet for this study

Summary

This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies.

The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).

Conditions

Interventions

DRUG

BG-68501

Planned doses administered orally.

DRUG

Fulvestrant

Standard dose administered via intramuscular injection.

DRUG

BGB-43395

Planned doses administered orally.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2028-04-30
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Israel
  • Moldova
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06257264 on ClinicalTrials.gov