Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06343402

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
350 (estimated)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI 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. The study includes dose escalation phase and dose expansion phase

Conditions

Interventions

TypeNameDescription
DRUGBBO-8520Participants will receive assigned dose of BBO-8520 orally (PO), QD
DRUGPembrolizumabPatients will receive IV pembrolizumab
DRUGBBO-10203Participants will receive assigned dose of BBO-8520 orally (PO), QD

Timeline

Start date
2024-05-22
Primary completion
2031-04-01
Completion
2031-09-01
First posted
2024-04-02
Last updated
2026-04-15

Locations

32 sites across 4 countries: United States, Australia, Canada, Spain

Regulatory

Source: ClinicalTrials.gov record NCT06343402. Inclusion in this directory is not an endorsement.