RecruitingPhase 1NCT06625775

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

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)


Sponsor

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Enrollment

392 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called BBO-10203 in people with advanced solid tumors, including certain types of breast cancer, lung cancer, and colorectal cancer. It is an early-phase trial focused on safety and finding the right dose, while also looking for early signs of effectiveness. **You may be eligible if...** - You have advanced breast cancer (HER2-positive or hormone receptor-positive), advanced colorectal cancer with a KRAS mutation, or advanced non-small cell lung cancer with a KRAS mutation - Your cancer is measurable on scans - You are in reasonably good physical condition (ECOG 0–1) - For HER2-positive breast cancer: you have tried at least 2 prior anti-HER2 treatments **You may NOT be eligible if...** - Your brain metastases are not stable - Your cancer has certain other genetic mutations targeted by approved therapies - Your heart function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBBO-10203

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

DRUGTrastuzumab

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

DRUGFulvestrant

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

DRUGRibociclib

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

DRUGFOLFOX

Patients will receive FOLFOX as infusion every 14 days

DRUGBevacizumab

Patients will receive bevacizumab as infusion every 28 days


Locations(36)

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

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06625775


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