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NCT06120283 · ClinicalTrials.gov registry record · Phase 1
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by BeiGene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT06120283: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by BeiGene.
NCT06120283 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor that is actively recruiting participants, run by BeiGene. The registered enrollment target is 300 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06120283, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, is actively recruiting participants, sponsored by BeiGene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG BGB-43395
- DRUG Elacestrant
Study Locations (20)
New South Wales
- Blacktown Cancer and Haematology Centre - Blacktown
- Southern Highlands Private Hospital - Bowral
- Concord Repatriation General Hospital - Concord
- Macquarie University - North Ryde
Texas
- The University of Texas Md Anderson Cancer Center - Houston
- Next Dallas - Irving
- Next Oncology - San Antonio
Victoria
- Austin Health - Heidelberg
- Peter Maccallum Cancer Centre - Melbourne
Other
- Fundacao Pio Xii Hospital de Amor de Barretos - Barretos
- Hospital Sirio Libanes Brasilia - Brasília
Colorado
- Sarah Cannon Research Institute (Scri) At Health One - Denver
Florida
- Florida Cancer Specialists and Research Institute - Lake Mary
Michigan
- Karmanos Cancer Institute - Detroit
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
What NCT06120283 shows while recruiting
NCT06120283 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (54% lower).
The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.
NCT06120283 names 20 study sites across 13 states, led by New South Wales, Texas, Victoria.
Frequently Asked Questions
What is clinical trial NCT06120283 about?
NCT06120283 is a clinical study titled "BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors". 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...
What is the current status of trial NCT06120283?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2023-12-01. Estimated completion is 2028-06.
What conditions does trial NCT06120283 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Breast Cancer, HER2-Negative Breast Cancer, Advanced Breast Cancer.
What interventions are being tested in trial NCT06120283?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), BGB-43395 (DRUG), Elacestrant (DRUG).
Who is sponsoring clinical trial NCT06120283?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06120283 being conducted?
This trial has 20 study locations across Colorado, Florida, Michigan, Missouri, North Carolina. 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 NCT06120283's enrollment target sits among peer trials
300 124th of 454 higher than 329 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung 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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