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Brief Title: Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Official Title: A Phase 1a/1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination With Pembrolizumab in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study
Study ID: NCT06343402
Brief Summary: A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer
Detailed Description: This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer. The study includes dose escalation phase, and expansion phase
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Norwalk Hospital, Norwalk, Connecticut, United States
Cleveland Clinic, Cleveland, Ohio, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
NEXT Oncology, Fairfax, Virginia, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia