Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
NCT06257264 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG BG-68501
- DRUG BGB-43395
Study Locations (20)
New South Wales
- Blacktown Cancer and Haematology Centre — Blacktown
- Saint Vincents Hospital Sydney — Darlinghurst
- Nepean Hospital — Kingswood
- Genesiscare North Shore — St Leonards
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Beijing Cancer Hospital — Beijing
California
- Hoag Memorial Presbyterian — Newport Beach
Florida
- Florida Cancer Specialists and Research Institute — Lake Mary
Missouri
- Washington University School of Medicine — St Louis
New Jersey
- Titan Health Partners Llc Dba Astera Cancer Care — East Brunswick
South Dakota
- Avera Cancer Institute — Sioux Falls
Texas
- Mary Crowley Cancer Research — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06257264
The ClinicalTrials.gov registry entry for NCT06257264 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Fulvestrant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06257264 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New South Wales, Beijing Municipality, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06257264 about?
NCT06257264 is a clinical study titled "A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors". 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 ...
What is the current status of trial NCT06257264?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 258 participants. The study started on 2024-03-11. Estimated completion is 2028-07.
What conditions does trial NCT06257264 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Ovarian Cancer, Advanced Solid Tumor, Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06257264?
The interventions under investigation include: Fulvestrant (DRUG), BG-68501 (DRUG), BGB-43395 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06257264?
This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06257264 being conducted?
This trial has 20 study locations across California, Florida, Missouri, New Jersey, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.