A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Active, not recruiting · Phase 1 · NCT06257264
Conditions: 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
At a glance
- Research payments reported, 2025
- $749,314
- U.S. investigators named
- 6
- Sites paid
- 7
- Planned or actual enrollment
- 103
About the trial
- Sponsor
- BeiGene
- Tested
- BG-68501 (drug), Fulvestrant (drug), BGB-43395 (drug)
- Dates
- Started 2024-03-11; completion 2027-08-27
- Results posted
- Not yet
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 studi…
From ClinicalTrials.gov, last updated 2026-10-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Beone Medicines Ltd. reported $749,314 in research payments for this study in 2025 (73 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Alain C. Mita, MD Medical Oncology · Newport Beach, CA
- Alexander Philipovskiy, M.D., PH.D Medical Oncology · Sanford, FL
- Bruno S. Fang, MD Hematology & Oncology · East Brunswick, NJ
- David C. Starks, MD Gynecologic Oncology · Sioux Falls, SD
- Minal A. Barve, M.D. Medical Oncology · Dallas, TX
- Monica M. Mita, MD Medical Oncology · San Antonio, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Titan Health PArtners, LLC D/b/a Astera Cancer Care $303,371
- Florida Cancer Specialist (scri) - Fort Myers $193,566
- Washington University $136,804
- Mary Crowley Cancer Research $51,502
- Hoag Memorial Hospital Presbyterian $26,521
- Florida Cancer Specialists & Research Institute, LLC $20,356
- Avera Mckennan Hospital & University Health Center, SD $17,193
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.