A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Running, not enrolling · Phase 1
Conditions studied: 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
In brief
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).
Key facts
- Study ID
- NCT06257264
- Run by
- BeiGene
- People needed
- 103
- Starts
- 2024-03-11
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hoag Memorial Presbyterian — Newport Beach, California, United States
- Florida Cancer Specialists and Research Institute — Lake Mary, Florida, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Titan Health Partners Llc Dba Astera Cancer Care — East Brunswick, New Jersey, United States
- Avera Cancer Institute — Sioux Falls, South Dakota, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
- Saint Vincents Hospital Sydney — Darlinghurst, New South Wales, Australia
- Nepean Hospital — Kingswood, New South Wales, Australia
- Genesiscare North Shore — St Leonards, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Cancer Research South Australia — Adelaide, South Australia, Australia
- Monash Health — Clayton, Victoria, Australia
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
- Hunan Cancer Hospital — Changsha, Hunan, China
- Shengjing Hospital of China Medical Universityhuaxiang Branch — Shenyang, Liaoning, China
- The First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
- 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
Full record on ClinicalTrials.gov
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