NCT06343402 Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
| NCT ID | NCT06343402 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2031-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 350 participants in total. It began in 2024-05-22 with a primary completion date of 2031-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
Eligibility Criteria
Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Patients with malignancy within the last 2 years as specified in the protocol * Patients with untreated or unstable brain metastases * Patients with known hypersensitivity to BBO-8520 or its excipients * For Cohorts 1b and 2b: * Patients with a known hypersensitivity to pembrolizumab or its excipients * Patients with active autoimmune disease of history of autoimmune disease that might recur * Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply
Contact & Investigator
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
✉ onkoras-101ct.gov@bridgebiooncology.com📞 650-405-8440
Frequently Asked Questions
Who can join the NCT06343402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343402 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06343402 currently recruiting?
Yes, NCT06343402 is actively recruiting participants. Contact the research team at onkoras-101ct.gov@bridgebiooncology.com for enrollment information.
Where is the NCT06343402 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, San Francisco, United States, Santa Monica, United States and 11 additional locations.
Who is sponsoring the NCT06343402 clinical trial?
NCT06343402 is sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics). The trial plans to enroll 350 participants.
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