RECRUITING

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

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Conditions

Solid Tumor, AdultMetastatic Breast CancerAdvanced Breast CancerHER2 Mutation-Related TumorsHER2-positive Metastatic Breast CancerKRAS Mutant Metastatic Colorectal CancerMetastatic Lung CancerMetastatic Colorectal CancerAdvanced Lung CancerHR-positive, HER2-negative Advanced Breast CancerHER2-positive Advanced Breast CancerBREAKER-101BridgeBio Oncology TherapeuticsBBOTPhase1Phase 1a/1bTrastuzumabBreastColorectalNon-Small Cell Lung CancerCRCNSCLCMetastatic CancerAdvanced CancerHER2-positiveHR-positiveHR-positive, HER2-negativeHER2-negative

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-10-29
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06625775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
  3. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  4. * Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)
  5. * Stable brain metastases
  6. * 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)
  7. * 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
  8. * BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
  9. * 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
  10. * 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
  1. * Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
  2. * 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)
  3. * Patients with untreated and/or non-stable brain metastases

Contacts and Locations

Study Contact

BBOT (BridgeBio Oncology Therapeutics)
CONTACT
650-391-9740
Breaker-101ct.gov@bridgebiooncology.com

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90095
United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02215
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
SCRI at Mary Crowley
Dallas, Texas, 75230
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Texas San Antonio (UTSA)
San Antonio, Texas, 78229
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-10-29
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • BREAKER-101
  • BridgeBio Oncology Therapeutics
  • BBOT
  • Phase1
  • Phase 1a/1b
  • Trastuzumab
  • Breast
  • Colorectal
  • Non-Small Cell Lung Cancer
  • CRC
  • NSCLC
  • Metastatic Cancer
  • Advanced Cancer
  • HER2-positive
  • HR-positive
  • HR-positive, HER2-negative
  • HER2-negative

Additional Relevant MeSH Terms

  • 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