A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
BG-68501: Planned doses administered orally.
Fulvestrant: Standard dose administered via intramuscular injection.
BGB-43395: Planned doses administered orally.
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).
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months
Number of participants with treatment-emergent AEs and SAEs. - Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501 — Up to approximately 24 months
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. - Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 monotherapy in participants with solid tumors — Up to approximately 24 months
RDFE of BG-68501 alone will be determined based upon the MTD or MAD. - Part 1: RDFE of BG-68501 in combination with fulvestrant and BGB-43395 in participants with HR+/HER2- BC — Up to approximately 24 months
RDFE of BG-68501 in combination with fulvestrant and BGB-43395 will be determined based upon the MTD or MAD. - Part 2: Objective Response Rate (ORR) — Up to approximately 20 months
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). CR and PR that is confirmed by repeat assessments, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Hoag Memorial Presbyterian | Newport Beach | California | |
| Florida Cancer Specialists and Research Institute | Lake Mary | Florida | |
| Washington University School of Medicine | St Louis | Missouri | |
| Titan Health Partners Llc Dba Astera Cancer Care | East Brunswick | New Jersey | |
| Avera Cancer Institute | Sioux Falls | South Dakota | |
| Mary Crowley Cancer Research | Dallas | Texas | |
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | |
| Saint Vincents Hospital Sydney | Darlinghurst | New South Wales | |
| Nepean Hospital | Kingswood | New South Wales | |
| Genesiscare North Shore | St Leonards | New South Wales | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Cancer Research South Australia | Adelaide | South Australia | |
| Monash Health | Clayton | Victoria | |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) | Guangzhou | Guangdong | |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| Shengjing Hospital of China Medical Universityhuaxiang Branch | Shenyang | Liaoning | |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | |
| Rambam Health Care Center | Haifa | Israel | |
| Shaare Zedek Medical Center | Jerusalem | Israel | |
| The Institute of Oncology, Arensia Exploratory Medicine | Chisinau | Moldova | |
| Auckland City Hospital | Auckland | New Zealand |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06257264 on ClinicalTrials.gov ↗ ← All trials in China