A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors (NCT06257264)
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Hoag Memorial Presbyterian — Newport Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- 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,
- Shaare Zedek Medical Center — Jerusalem,
- The Institute of Oncology, Arensia Exploratory Medicine — Chisinau,
- Auckland City Hospital — Auckland,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.