Actively Recruiting
A Phase 1a/1b Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Advanced KRASG12C Mutant Non-Small Cell Lung Cancer
Led by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Updated on 2026-05-05
350
Participants Needed
35
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, tolerability, pharmacokinetics, and early antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, in adults with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 1 open-label study aims to understand how BBO-8520 works alone and in combination with pembrolizumab and BBO-10203 in this patient population. Participants will receive BBO-8520 orally once daily at various dose levels. Some groups will receive BBO-8520 alone, while others will receive it combined with pembrolizumab infusions and/or BBO-10203, also given orally once daily. The study includes dose escalation phases to find appropriate doses and dose expansion phases to further evaluate treatment effects. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities over approximately three years. Researchers will assess preliminary antitumor activity, pharmacokinetics, and overall survival. Evaluations will include clinical assessments and safety monitoring to understand the treatment's effects and tolerability throughout the study period.
CONDITIONS
Brief Title
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer with a KRAS G12C mutation
- Measurable disease by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adults aged 18 years or older
You will not qualify if you...
- History of any malignancy within the last 2 years as defined in the protocol
- Untreated or unstable brain metastases
- Known hypersensitivity to BBO-8520 or its excipients
- For combination therapy cohorts: known hypersensitivity to pembrolizumab or its excipients
- Active or history of autoimmune disease that may recur
- History of interstitial lung disease or pneumonitis requiring steroids, or current interstitial lung disease/pneumonitis
- Other exclusion criteria as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive assigned doses of BBO-8520 orally once a day, either alone or in combination with pembrolizumab infusion and/or BBO-10203, to evaluate safety, tolerability, pharmacokinetics, and efficacy.
Regular visits for dosing and assessments throughout treatment duration
Duration - Up to approximately 3 years
Participants are monitored for adverse events, dose-limiting toxicities, and overall survival following treatment completion.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 35 locations
1
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California - San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States, 90404
Actively Recruiting
5
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
Actively Recruiting
8
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61603
Actively Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66205
Actively Recruiting
10
Henry Ford Cancer - Detroit
Detroit, Michigan, United States, 48282
Actively Recruiting
11
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
12
Perlmutter Cancer Center - NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
USOR - Oncology Associates of Oregon, P.C
Eugene, Oregon, United States, 97401
Actively Recruiting
16
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
Oncology Consultants Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
18
USOR - Texas Oncology - (DFW) Waco
Waco, Texas, United States, 76710
Actively Recruiting
19
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
20
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
21
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
22
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
23
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
24
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
25
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Actively Recruiting
26
Peninsula & South Eastern Hematology and Oncology Group (PAS)
Frankston, Victoria, Australia, 3199
Actively Recruiting
27
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3051
Actively Recruiting
28
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
29
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
30
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
31
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
32
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
33
START Barcelona - Hospital HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
34
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
35
Hospital Universitario Quirónsalud Madrid
Madrid, Spain, 28223
Actively Recruiting
Research Team
T
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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