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
2 other identifiers
interventional
350
5 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 nonsmall-cell-lung-cancer
Started May 2024
Longer than P75 for phase_1 nonsmall-cell-lung-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedStudy Start
First participant enrolled
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
May 5, 2026
March 1, 2026
6.9 years
March 22, 2024
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse Events
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
approximately 3 years
Dose-limiting toxicities (DLTs)
Number of participants with dose limiting toxicities
approximately 3 years
Secondary Outcomes (8)
To evaluate preliminary antitumor activity of BBO-8520
approximately 3 years
To evaluate preliminary antitumor activity of BBO-8520
approximately 3 years
To evaluate preliminary antitumor activity of BBO-8520
approximately 3 years
Overall Survival (OS)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
approximately 3 years
- +3 more secondary outcomes
Study Arms (8)
Cohort 1a - Dose Escalation/Dose Finding Monotherapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
Cohort 2a - Dose Expansion Monotherapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Cohort 2b - Dose Expansion Combination Therapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination Therapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Cohort 1b - Dose Expansion Doublet Combination Therapy
EXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination Therapy
EXPERIMENTALParticipants 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)
Cohort 1b - Dose Expansion Triplet Combination Therapy
EXPERIMENTALParticipants 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)
Interventions
Patients will receive IV pembrolizumab
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
April 2, 2024
Study Start
May 22, 2024
Primary Completion (Estimated)
April 1, 2031
Study Completion (Estimated)
September 1, 2031
Last Updated
May 5, 2026
Record last verified: 2026-03