🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06625775
Recruiting Phase 1

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

NCT06625775 · tracked via the Priya Life Science USA tracker
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Phase
Phase 1
Started
2024-10-29
Last updated
2026-09-09

Condition(s) studied

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

Investigational drug(s) / intervention(s)

BBO-10203 →Trastuzumab →Fulvestrant →Ribociclib →FOLFOX →Bevacizumab →

BBO-10203: Participants will receive assigned dose of BBO-10203 orally once daily

Trastuzumab: Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days

Fulvestrant: Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)

Ribociclib: Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)

FOLFOX: Patients will receive FOLFOX as infusion every 14 days

Bevacizumab: Patients will receive bevacizumab as infusion every 28 days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 Other inclusion/exclusion criteria are specified in the protocol

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California Recruiting
University of California Los Angeles Los Angeles California Recruiting
University of California San Diego Moores Cancer Center San Diego California Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Indiana University Simon Comprehensive Cancer Center Indianapolis Indiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Insitute Boston Massachusetts Recruiting
St. Lukes Hospital of Kansas City Kansas City Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Columbia University Irving Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
SCRI at Mary Crowley Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
University of Texas San Antonio (UTSA) San Antonio Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Wisconsin Institute for Medical Research Madison Wisconsin Recruiting
Scientia Clinical Research Randwick New South Wales Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Liga Contra o Câncer Natal Rio Grande do Norte Recruiting
FUTTURA Oncologia Porto Alegre Rio Grande do Sul Recruiting
Hospital São Lucas da PUCRS Porto Alegre Rio Grande do Sul Recruiting
Instituto do Câncer do Estado de São Paulo - ICESP São Paulo São Paulo Recruiting
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda São Paulo São Paulo Recruiting
IEPE - Unimed Sorocaba Sorocaba São Paulo Recruiting
Institut régional du Cancer de Montpellier - Val d'Aurelle Montpellier Occitanie Recruiting
Institut Curie - René-Huguenin Hospital Saint-Cloud Paris Recruiting
lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain Saint-Herblain Pays de la Loire Region Recruiting
Institut Bergonie Bordeaux France Recruiting
Centre Léon Bérard Lyon France Recruiting
Institut Gustave Roussy Villejuif Île-de-France Region Recruiting
Asan Medical Center (AMC) Seoul Seoul Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Hospital Universitario Vall d'Hebron Barcelona Catalonia Recruiting
Hospital Beata Maria Ana Madrid Madrid Recruiting
Hospital Quiron Madrid - NEXT Oncology Pozuelo de Alarcón Madrid Recruiting
IOB Institute of Oncology - Hospital Quironsalud Barcelona Barcelona Spain Recruiting
START Barcelona - HM Nou Delfos Hospital Barcelona Spain Recruiting

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Herceptin (trastuzumab) drug profile → 📄 Kisqali (ribociclib) drug profile → 📄 Avastin (bevacizumab) drug profile →

More TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06625775 on ClinicalTrials.gov ↗ ← All trials in the USA