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NCT06343402 · ClinicalTrials.gov registry record · Phase 1
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT06343402: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics).
NCT06343402 is a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC that is actively recruiting participants, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics). The registered enrollment target is 250 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06343402, a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, is actively recruiting participants, sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
Primary Outcome
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG BBO-8520
Study Locations (20)
California
- University of California - San Diego Moores Cancer Center - La Jolla
- University of California San Francisco - San Francisco
- UCLA Health - Santa Monica Cancer Care - Santa Monica
New York
- Roswell Park Cancer Institute - Buffalo
- Perlmutter Cancer Center - NYU Langone Health - New York
- Memorial Sloan Kettering Cancer Center - New York
Connecticut
- Yale Cancer Center - New Haven
- Norwalk Hospital - Norwalk
Texas
- Oncology Consultants Texas Medical Center - Houston
- USOR - Texas Oncology - (DFW) Waco - Waco
Alabama
- O'Neal Comprehensive Cancer Center at UAB - Birmingham
Colorado
- University of Colorado Cancer Center - Aurora
Illinois
- OSF Saint Francis Medical Center - Peoria
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-05-22 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
What NCT06343402 shows while recruiting
NCT06343402 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (62% lower).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06343402 names 20 study sites across 14 states, led by California, New York, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06343402 about?
NCT06343402 is a clinical study titled "Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer". A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten r...
What is the current status of trial NCT06343402?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2024-05-22. Estimated completion is 2028-02.
What conditions does trial NCT06343402 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, NSCLC, Metastatic Non Small Cell Lung Cancer, Metastatic Lung Cancer, Kras G12C.
What interventions are being tested in trial NCT06343402?
The interventions under investigation include: Pembrolizumab (DRUG), BBO-8520 (DRUG).
Who is sponsoring clinical trial NCT06343402?
This trial is sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics), which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06343402 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06343402's enrollment target sits among peer trials
250 144th of 454 higher than 309 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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