Actively Recruiting
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Led by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Updated on 2026-04-13
392
Participants Needed
36
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
CONDITIONS
Official Title
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced unresectable or metastatic HER2-positive advanced breast cancer, HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer, or KRAS mutant advanced non-small cell lung cancer
- Measurable disease by RECIST v1.1 (except evaluable bone-only disease allowed for HR-positive HER2-negative advanced breast cancer)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate left ventricular ejection fraction assessed by ECHO or MUGA (only for BBO-10203 plus trastuzumab cohorts)
- Stable brain metastases
- For HER2-positive advanced breast cancer: at least 2 prior lines of anti-HER2 therapy or 1 prior line if no other standard of care available
- Monotherapy cohort patients with HR-positive, HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer or non-small cell lung cancer must have disease progression after at least one line of standard of care or be unlikely to benefit from it
- For BBO-10203 plus fulvestrant cohort with HR-positive, HER2-negative advanced breast cancer: confirmed PIK3CA mutation and prior treatment with a CDK4/6 inhibitor
- For BBO-10203 plus fulvestrant plus ribociclib cohort with HR-positive, HER2-negative advanced breast cancer: confirmed PIK3CA mutation and no prior systemic therapy in advanced breast cancer setting
- For BBO-10203 plus FOLFOX plus bevacizumab cohort with KRAS mutant advanced colorectal cancer: one prior line of irinotecan-containing therapy allowed but not required
You will not qualify if you...
- KRAS mutant advanced colorectal cancer patients with KRAS G12R mutation, BRAFV600E mutation, HER2 amplification, or dMMR/MSI-H tumors
- KRAS mutant advanced non-small cell lung cancer patients with KRAS G12R mutation or tumors with other targetable driver mutations such as EGFR, anaplastic lymphoma kinase, ROS1, BRAF, RET, MET, EGFR exon 20 insertion, NTRK, or HER2
- Patients with untreated or unstable brain metastases
- Other exclusion criteria as specified in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
4
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana-Farber Cancer Insitute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
St. Lukes Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
10
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
SCRI at Mary Crowley
Dallas, Texas, United States, 75230
Actively Recruiting
15
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Texas San Antonio (UTSA)
San Antonio, Texas, United States, 78229
Actively Recruiting
18
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
19
Wisconsin Institute for Medical Research
Madison, Wisconsin, United States, 53792
Actively Recruiting
20
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
21
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
22
Institut régional du Cancer de Montpellier - Val d'Aurelle
Montpellier, Occitanie, France, 34298
Actively Recruiting
23
Institut Curie - René-Huguenin Hospital
Saint-Cloud, Paris, France, 92210
Actively Recruiting
24
lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain
Saint-Herblain, Pays de la Loire Region, France, 44805
Actively Recruiting
25
Institut Bergonie
Bordeaux, France, 33000
Actively Recruiting
26
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
27
Institut Gustave Roussy
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
28
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
29
Hospital Beata Maria Ana
Madrid, Madrid, Spain, 28007
Actively Recruiting
30
Hospital Quiron Madrid - NEXT Oncology
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
31
IOB Institute of Oncology - Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
32
START Barcelona - HM Nou Delfos Hospital
Barcelona, Spain, 08023
Actively Recruiting
33
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
34
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
35
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
36
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
B
BBOT (BridgeBio Oncology Therapeutics)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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