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RECRUITING

NCT06625775

PHASE1

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

Sponsor: 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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

392

Start Date

2024-10-29

Completion Date

2028-11

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Solid Tumor, Adult Metastatic Breast Cancer Advanced Breast Cancer HER2 Mutation-Related Tumors HER2-positive Metastatic Breast Cancer KRAS Mutant Metastatic Colorectal Cancer Metastatic Lung Cancer Metastatic Colorectal Cancer Advanced Lung Cancer HR-positive, HER2-negative Advanced Breast Cancer HER2-positive Advanced Breast Cancer

Interventions

DRUG

BBO-10203

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

DRUG

Trastuzumab

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

DRUG

Fulvestrant

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

DRUG

Ribociclib

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

DRUG

FOLFOX

Patients will receive FOLFOX as infusion every 14 days

DRUG

Bevacizumab

Patients will receive bevacizumab as infusion every 28 days

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

Locations (34)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

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

Memorial Sloan Kettering Cancer Center

New York, New York, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

SCRI at Mary Crowley

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Texas San Antonio (UTSA)

San Antonio, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Wisconsin Institute for Medical Research

Madison, Wisconsin, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Institut régional du Cancer de Montpellier - Val d'Aurelle

Montpellier, Occitanie, France

Institut Curie - René-Huguenin Hospital

Saint-Cloud, Paris, France

lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain

Saint-Herblain, Pays de la Loire Region, France

Institut Bergonie

Bordeaux, France

Centre Léon Bérard

Lyon, France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital Beata Maria Ana

Madrid, Madrid, Spain

Hospital Quiron Madrid - NEXT Oncology

Pozuelo de Alarcón, Madrid, Spain

IOB Institute of Oncology - Hospital Quironsalud Barcelona

Barcelona, Spain

START Barcelona - HM Nou Delfos Hospital

Barcelona, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (34)