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NCT06257264 · ClinicalTrials.gov registry record · Phase 1
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by BeiGene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 258
- Enrollment target
- 20
- Study locations
NCT06257264: Recruiting Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by BeiGene.
NCT06257264 is a Phase 1 study of Breast Cancer and Prostate Cancer that is actively recruiting participants, run by BeiGene. The registered enrollment target is 258 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06257264, a Phase 1 study of Breast Cancer and Prostate Cancer, is actively recruiting participants, sponsored by BeiGene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 258 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Number of participants with treatment-emergent AEs and SAEs.
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 |
What NCT06257264 shows while recruiting
NCT06257264 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
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.
NCT06257264 names 20 study sites across 16 states, led by New South Wales, Beijing Municipality, California.
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.
What interventions are being tested in trial NCT06257264?
The interventions under investigation include: Fulvestrant (DRUG), BG-68501 (DRUG), BGB-43395 (DRUG).
Who is sponsoring clinical trial NCT06257264?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06257264's enrollment target sits among peer trials
258 317th of 1224 higher than 908 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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