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Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
NCT06343402 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06343402
The ClinicalTrials.gov registry entry for NCT06343402 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 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics), which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06343402 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, Connecticut. 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 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 Lung Cancer, Metastatic Non-Small Cell Lung Cancer, KRAS G12C. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06343402?
The interventions under investigation include: Pembrolizumab (DRUG), BBO-8520 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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