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NCT06685718 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by BeiGene.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT06685718: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, sponsored by BeiGene.
NCT06685718 is a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer that is actively recruiting participants, run by BeiGene. The registered enrollment target is 93 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06685718, a Phase 1 study of Non-Small Cell Lung Cancer and Lung Cancer, is actively recruiting participants, sponsored by BeiGene.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC. The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.
Primary Outcome
Number of participants with AEs and SAEs, including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Conditions Studied
Interventions
- DRUG BG-60366
Study Locations (20)
New South Wales
- Blacktown Cancer and Haematology Centre - Blacktown
- Liverpool Hospital - Liverpool
Victoria
- Austin Health - Heidelberg
- Peter Maccallum Cancer Centre - Melbourne
Colorado
- University of Colorado - Denver
Massachusetts
- Dana Farber Cancer Institute - Boston
Missouri
- Washington University School of Medicine Siteman Cancer Center - St Louis
New York
- Memorial Sloan Kettering Cancer Center Mskcc - New York
Ohio
- Ohio State University - Columbus
Texas
- The University of Texas Md Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
What NCT06685718 shows while recruiting
NCT06685718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (86% lower).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which BG-60366 is the first listed.
NCT06685718 names 20 study sites across 18 states, led by New South Wales, Victoria, Colorado.
Frequently Asked Questions
What is clinical trial NCT06685718 about?
NCT06685718 is a clinical study titled "A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer". This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is desi...
What is the current status of trial NCT06685718?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2024-11-26. Estimated completion is 2028-04.
What conditions does trial NCT06685718 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), EGFR Mutation-Related Tumors.
What interventions are being tested in trial NCT06685718?
The interventions under investigation include: BG-60366 (DRUG).
Who is sponsoring clinical trial NCT06685718?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06685718 being conducted?
This trial has 20 study locations across Colorado, Massachusetts, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06685718's enrollment target sits among peer trials
93 251st of 454 higher than 204 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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