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New cancer drug BBO-10203 enters first human trials

NCT ID NCT06625775

Disease control Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This early-stage study tests a new drug called BBO-10203 in people with advanced solid tumors (breast, lung, or colorectal cancer) that have not responded to standard treatments. The drug is designed to block two cancer-driving proteins (PI3K and RAS). Researchers will check safety, side effects, and the best dose, both alone and combined with other cancer drugs. About 392 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BBO-10203 (a drug that targets PI3K and RAS proteins)
What this could lead to
If successful, this could lead to a new treatment option for advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) study, so the drug may not be safe or effective. Side effects are unknown, and it may not work for all cancer types tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 392 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm colorectal cancer colorectal neoplasm HER2 positive breast carcinoma hormone receptor-positive breast cancer lung cancer lung carcinoma lung neoplasm metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Advanced lung cancer HER2 mutation-related tumors HER2-positive advanced breast cancer HER2-positive metastatic breast cancer HR-positive, HER2-negative advanced breast cancer KRAS mutant metastatic colorectal cancer Metastatic breast cancer Metastatic colorectal cancer Metastatic lung cancer Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    44 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center (AMC)

    RECRUITING

    Seoul, Seoul, 05505, South Korea

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

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

    RECRUITING

    São Paulo, São Paulo, 01317, Brazil

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Insitute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • FUTTURA Oncologia

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90470, Brazil

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hospital Beata Maria Ana

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Quiron Madrid - NEXT Oncology

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital São Lucas da PUCRS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610, Brazil

  • Hospital Universitari Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • IEPE - Unimed Sorocaba

    RECRUITING

    Sorocaba, São Paulo, 18056, Brazil

  • IOB Institute of Oncology - Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • Indiana University Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Institut Curie - René-Huguenin Hospital

    RECRUITING

    Saint-Cloud, Paris, 92210, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Île-de-France Region, 94805, France

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

    RECRUITING

    Montpellier, Occitanie, 34298, France

  • Instituto do Câncer do Estado de São Paulo - ICESP

    RECRUITING

    São Paulo, São Paulo, 01246, Brazil

  • Liga Contra o Câncer

    RECRUITING

    Natal, Rio Grande do Norte, 59062, Brazil

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • SCRI at Mary Crowley

    RECRUITING

    Dallas, Texas, 75230, United States

  • START Barcelona - HM Nou Delfos Hospital

    RECRUITING

    Barcelona, 08023, Spain

  • Scientia Clinical Research

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • St. Lukes Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Diego Moores Cancer Center

    RECRUITING

    San Diego, California, 92093, United States

  • University of Texas San Antonio (UTSA)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wisconsin Institute for Medical Research

    RECRUITING

    Madison, Wisconsin, 53792, United States

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

    RECRUITING

    Saint-Herblain, Pays de la Loire Region, 44805, France

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