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

Last updated: November 7, 2025
Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Overall Status: Active - Recruiting

Phase

1

Condition

Colorectal Cancer

Breast Cancer

Neoplasm Metastasis

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

    Site Not Available

  • Scientia Clinical Research

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego 5391811, California 5332921 92037
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Dana-Farber Cancer Insitute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana-Farber Cancer Insitute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    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

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 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

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas San Antonio (UTSA)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • SCRI at Mary Crowley

    Dallas 4684888, Texas 4736286 75230
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • University of Texas San Antonio (UTSA)

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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