Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Start Date
5/22/2024
Completion Date
9/1/2031
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BBO-8520
Pembrolizumab
BBO-10203
Conditions
Locations
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama 35233
United States
University of California - San Diego Moores Cancer Center
La Jolla, California 92093
United States
University of California San Francisco
San Francisco, California 94158
United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California 90404
United States
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Yale Cancer Center
New Haven, Connecticut 06510
United States
Norwalk Hospital
Norwalk, Connecticut 06850
United States
OSF Saint Francis Medical Center
Peoria, Illinois 61603
United States
University of Kansas Medical Center
Kansas City, Kansas 66205
United States
Henry Ford Cancer - Detroit
Detroit, Michigan 48282
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Perlmutter Cancer Center - NYU Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
USOR - Oncology Associates of Oregon, P.C
Eugene, Oregon 97401
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Oncology Consultants Texas Medical Center
Houston, Texas 77030
United States
USOR - Texas Oncology - (DFW) Waco
Waco, Texas 76710
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
NEXT Oncology
Fairfax, Virginia 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Northwest Medical Specialties
Tacoma, Washington 98405
United States
Kinghorn Cancer Centre
Darlinghurst, New South Wales 2010
Australia
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
Australia
Peninsula & South Eastern Hematology and Oncology Group (PAS)
Frankston, Victoria 3199
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3051
Australia
Linear Clinical Research
Nedlands, Western Australia 6009
Australia
Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
Canada
The Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C4
Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
Rigshospitalet
Copenhagen, 2100
Denmark
START Barcelona - Hospital HM Nou Delfos
Barcelona, 08023
Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
Spain