Recruiting INTERVENTIONAL NCT06257264

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

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

Sponsor: BeiGene

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

Interventions BG-68501 BGB-43395 Fulvestrant

Updated 21 times since 2024 Last updated: Apr 20, 2026 Started: Mar 11, 2024 Primary completion: Apr 1, 2028 Completion: Jul 1, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06257264, this observational or N/A phase trial focuses on Advanced Solid Tumor and Bladder Cancer and remains actively recruiting participants. Sponsored by BeiGene, it has been updated 21 times since 2024, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

21 versions recorded

Apr 23, 2026 — Present [daily]

Recruiting

Phase: PHASE1 → None
Mar 2026 — Apr 2026 [monthly]

Recruiting PHASE1
Jan 2026 — Mar 2026 [monthly]

Recruiting PHASE1
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE1
Oct 2025 — Dec 2025 [monthly]

Recruiting PHASE1

▶ Show 16 earlier versions

Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE1
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE1
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE1
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE1
May 2025 — Jun 2025 [monthly]

Recruiting PHASE1
Apr 2025 — May 2025 [monthly]

Recruiting PHASE1
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE1
Feb 2025 — Mar 2025 [monthly]

Recruiting PHASE1
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE1
Dec 2024 — Jan 2025 [monthly]

Recruiting PHASE1
Nov 2024 — Dec 2024 [monthly]

Recruiting PHASE1
Sep 2024 — Nov 2024 [monthly]

Recruiting PHASE1
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE1
May 2024 — Jul 2024 [monthly]

Recruiting PHASE1
Mar 2024 — May 2024 [monthly]

Recruiting PHASE1

First recorded

Eligibility 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).

Contact Information

Sponsor contact:

BeiGene

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Auckland, New Zealand , Beijing, China , Beijing, China , Blacktown, Australia , Changsha, China , Chisinau, Moldova , Clayton, Australia , Dallas, United States , Darlinghurst, Australia and 14 more locations