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Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
NCT06343402 · TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
In plain English
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Official title
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
About this study
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
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
Study design
Enrollment target: 350 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-22
Estimated completion: 2031-09
Last updated: 2026-04-15
Interventions
Drug: BBO-8520Drug: PembrolizumabDrug: BBO-10203
Primary outcomes
- • Adverse Events (approximately 3 years)
- • Dose-limiting toxicities (DLTs) (approximately 3 years)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · industry
Contacts & investigators
ContactTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · contact · onkoras-101ct.gov@bridgebiooncology.com · 650-405-8440
All locations (32)
O'Neal Comprehensive Cancer Center at UABRecruiting
Birmingham, Alabama, United States
University of California - San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
UCLA Health - Santa Monica Cancer CareRecruiting
Santa Monica, California, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Norwalk HospitalRecruiting
Norwalk, Connecticut, United States
OSF Saint Francis Medical CenterRecruiting
Peoria, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Henry Ford Cancer - DetroitRecruiting
Detroit, Michigan, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Perlmutter Cancer Center - NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
USOR - Oncology Associates of Oregon, P.CRecruiting
Eugene, Oregon, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Oncology Consultants Texas Medical CenterRecruiting
Houston, Texas, United States
USOR - Texas Oncology - (DFW) WacoRecruiting
Waco, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
NEXT OncologyRecruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States
Kinghorn Cancer CentreRecruiting
Darlinghurst, New South Wales, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
The Queen Elizabeth HospitalRecruiting
Woodville South, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group (PAS)Recruiting
Frankston, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
The Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Hospital Universitario Quirónsalud MadridRecruiting
Madrid, Spain