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
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
O'Neal Comprehensive Cancer Center at UAB
RECRUITING
Birmingham
California
University of California - San Diego Moores Cancer Center
RECRUITING
La Jolla
University of California San Francisco
RECRUITING
San Francisco
UCLA Health - Santa Monica Cancer Care
RECRUITING
Santa Monica
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Norwalk Hospital
RECRUITING
Norwalk
Illinois
OSF Saint Francis Medical Center
RECRUITING
Peoria
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Michigan
Henry Ford Cancer - Detroit
RECRUITING
Detroit
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Perlmutter Cancer Center - NYU Langone Health
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
USOR - Oncology Associates of Oregon, P.C
RECRUITING
Eugene
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Oncology Consultants Texas Medical Center
RECRUITING
Houston
USOR - Texas Oncology - (DFW) Waco
RECRUITING
Waco
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
NEXT Oncology
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Northwest Medical Specialties
RECRUITING
Tacoma
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Kinghorn Cancer Centre
RECRUITING
Darlinghurst
Peninsula & South Eastern Hematology and Oncology Group (PAS)
RECRUITING
Frankston
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Linear Clinical Research
RECRUITING
Nedlands
The Queen Elizabeth Hospital
RECRUITING
Woodville South
Canada
Juravinski Cancer Centre
RECRUITING
Hamilton
Jewish General Hospital
RECRUITING
Montreal
The Princess Margaret Cancer Centre
RECRUITING
Toronto
Spain
Hospital Universitario Quirónsalud Madrid
RECRUITING
Madrid
Contact Information
Primary
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
onkoras-101ct.gov@bridgebiooncology.com
650-405-8440
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2031-09
Participants
Target number of participants: 350
Treatments
Experimental: Cohort 1a - Dose Escalation/Dose Finding Monotherapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Experimental: Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
Experimental: Cohort 2a - Dose Expansion Monotherapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Experimental: Cohort 2b - Dose Expansion Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Experimental: Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Experimental: Cohort 1b - Dose Expansion Doublet Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Experimental: Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)
Experimental: Cohort 1b - Dose Expansion Triplet Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)
Related Therapeutic Areas
Sponsors
Leads: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)