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

Last updated: June 18, 2026
Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Colorectal Cancer

Neoplasms

Treatment

BBO-10203

Trastuzumab

FOLFOX

Clinical Study ID

NCT06625775
TBBO10203-101
BREAKER-101
2024-519445-29-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advancedcolorectal 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 whereevaluable 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 ofanti-HER2-directed therapy. Only 1 prior line is acceptable where there is no otherregionally available standard of care (SoC)

  • Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC oraNSCLC: Must have progression on, or disease recurrence after at least one line ofSOC treatment or in the opinion of the investigator, would be unlikely to tolerateor derive clinically meaningful benefit from SoC therapy

  • BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negativeaBC: 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 aBCsetting permitted

  • BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC:One prior line of irinotecan-containing therapy for locally advanced or metastaticCRC is allowed but not required

Exclusion

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 othertargetable 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

Study Design

Total Participants: 392
Treatment Group(s): 6
Primary Treatment: BBO-10203
Phase: 1
Study Start date:
October 29, 2024
Estimated Completion Date:
November 30, 2028

Study 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.

Connect with a study center

  • Scientia Clinical Research

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • FUTTURA Oncologia

    Porto Alegre, Rio Grande do Sul 90470
    Brazil

    Active - Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul 90610
    Brazil

    Active - Recruiting

  • IEPE - Unimed Sorocaba

    Sorocaba, São Paulo 18056
    Brazil

    Active - Recruiting

  • Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo 01317
    Brazil

    Active - Recruiting

  • Institut régional du Cancer de Montpellier - Val d'Aurelle

    Montpellier, Occitanie 34298
    France

    Active - Recruiting

  • Institut Curie - René-Huguenin Hospital

    Saint-Cloud, Paris 92210
    France

    Active - Recruiting

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

    Saint-Herblain, Pays de la Loire Region 44805
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region 94805
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33000
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69008
    France

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Active - Recruiting

  • Hospital Beata Maria Ana

    Madrid, Madrid 28007
    Spain

    Active - Recruiting

  • Hospital Quiron Madrid - NEXT Oncology

    Pozuelo de Alarcón, Madrid 28223
    Spain

    Active - Recruiting

  • IOB Institute of Oncology - Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • START Barcelona - HM Nou Delfos Hospital

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego, California 92093
    United States

    Active - Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Dana-Farber Cancer Insitute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana-Farber Cancer Insitute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • St. Lukes Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • SCRI at Mary Crowley

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas San Antonio (UTSA)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Wisconsin Institute for Medical Research

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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