BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (NCT06120283)
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Who can join: Review the eligibility criteria below.
Location: Sarah Cannon Research Institute (Scri) At Health One — Denver, Colorado
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 (62 Sites)
Showing the first 25 of 62 sites.
- Sarah Cannon Research Institute (Scri) At Health One — Denver, Colorado
- Florida Cancer Specialists and Research Institute — Lake Mary, Florida
- Karmanos Cancer Institute — Detroit, Michigan
- Washington University School of Medicine — St Louis, Missouri
- Duke Cancer Center — Durham, North Carolina
- James Cancer Hospital and Solove Research Institute — Columbus, Ohio
- Scri Oncology Partners — Nashville, Tennessee
- The University of Texas Md Anderson Cancer Center — Houston, Texas
- Next Dallas — Irving, Texas
- Next Oncology — San Antonio, Texas
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales
- Southern Highlands Private Hospital — Bowral, New South Wales
- Concord Repatriation General Hospital — Concord, New South Wales
- Macquarie University — North Ryde, New South Wales
- Townsville University Hospital — Douglas, Queensland
- Genesiscare St Andrews — Adelaide, South Australia
- Austin Health — Heidelberg, Victoria
- Peter Maccallum Cancer Centre — Melbourne, Victoria
- Fundacao Pio Xii Hospital de Amor de Barretos — Barretos,
- Hospital Sirio Libanes Brasilia — Brasília,
- Centro de Pesquisas Oncologicas Cepon — Florianópolis,
- Liga Norte Riograndene Contra O Cancer — Natal,
- Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude — Petrópolis,
- Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia — Porto Algre,
- Instituto Nacional de Cancer — Rio de Janeiro,
📞 Contact the Study Coordinator
Phone: (877) 828-5568
Email: clinicaltrials@beonemed.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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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- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
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Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.