OncRef

Clinical Trial: NCT06257264

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:BeiGene
Information Provided By:BeOne Medicines
Last Update Posted:2026-10-20

Study Overview

Brief 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).

Official Title

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

Conditions

Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced Solid Tumor, Endometrial Cancer, Prostate Cancer, TNBC - Triple-Negative Breast Cancer, GastroEsophageal Cancer, Bladder Cancer

Intervention / Treatment

  • Drug: BG-68501
  • Drug: Fulvestrant
  • Drug: BGB-43395

Other Study ID Numbers

  • BG-68501-101
  • CTR20243059
  • 2024-517324-19-00

Start Date (Actual)

2024-03-11

Primary Completion Date (Actual)

2026-08-27

Study Completion Date (Estimated)

2027-08-27

Enrollment (Actual)

103

Study Type

Interventional

Phase

Phase 1