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

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.

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 Cancer
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Related 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 Cancer

Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Indianapolis

Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana-Farber Cancer Insitute, Boston, Massachusetts, United States, 02215

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Dallas

SCRI at Mary Crowley, Dallas, Texas, United States, 75230

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

University of Texas San Antonio (UTSA), San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Study Record Dates

2028-11