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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

NCT06625775•TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
•Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
•Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)
•Stable brain metastases
•Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)
•Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy
•BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
•BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted
•BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required

Exclusion Criteria

•Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
•Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
•Patients with untreated and/or non-stable brain metastases

Locations (32)

University of California Los Angeles

Los Angeles, California, United States

University of California San Diego Moores Cancer Center

San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Insitute

Boston, Massachusetts, United States

St. Lukes Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Irving Medical Center

New York, New York, United States

Key Dates

Start Date

October 29, 2024

Primary Completion Date

November 1, 2028

Completion Date

November 1, 2028

Last Updated

March 18, 2026

Enrollment

392

ESTIMATED participants

Conditions

Solid Tumor, AdultMetastatic Breast CancerAdvanced Breast CancerHER2 Mutation-Related TumorsHER2-positive Metastatic Breast CancerKRAS Mutant Metastatic Colorectal CancerMetastatic Lung CancerMetastatic Colorectal CancerAdvanced Lung CancerHR-positive, HER2-negative Advanced Breast CancerHER2-positive Advanced Breast Cancer

Interventions

BBO-10203

DRUG

Trastuzumab

DRUG

Fulvestrant

DRUG

Ribociclib

DRUG

FOLFOX

DRUG

Bevacizumab

DRUG

Contacts

BBOT (BridgeBio Oncology Therapeutics)

CONTACT

650-405-8440 Breaker-101ct.gov@bridgebiooncology.com

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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