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

Launched by THERAS, INC., D/B/A BBOT (BRIDGEBIO ONCOLOGY THERAPEUTICS) · Oct 1, 2024

Keywords

ClinConnect Summary

The BREAKER-101 clinical trial is a study looking at a new treatment called BBO-10203 for patients with advanced solid tumors, including certain types of breast and colorectal cancers. This is the first time this treatment is being tested in humans, and the trial aims to find out how safe it is, how well it works, and how the body processes it. Some patients will receive BBO-10203 alone, while others may receive it alongside another medication called trastuzumab, which is commonly used for HER2-positive breast cancer.

To be eligible for this trial, patients must have specific types of advanced cancer that have either spread to other parts of the body or cannot be surgically removed. They should have already tried at least two previous treatments for breast cancer or have experienced progression of their disease after standard treatments for colorectal or lung cancers. Participants can expect close monitoring throughout the study, and there are specific guidelines about who can join to ensure safety, such as not having certain genetic mutations or untreated brain metastases. This study is currently recruiting participants, and those interested should discuss it with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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