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

a study on Solid Tumor Breast Cancer HER2 Colorectal Cancer Lung Cancer Lung Tumor Colorectal Tumor Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Marla D. Lipsyc-Sharf, MD (ucla)
Headshot of Marla D. Lipsyc-Sharf
Marla D. Lipsyc-Sharf

Description

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.

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)

Details

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.

Keywords

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, 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, Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Non-Small-Cell Lung Carcinoma, Neoplasm Metastasis, Fulvestrant, ribociclib, Folfox protocol, Bevacizumab, BBO-10203, FOLFOX, BBO-10203 + Trastuzumab, BBO-10203 + Fulvestrant, BBO10203 + Fulvestrant + Ribociclib, BBO10203 + FOLFOX + Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • Fred Hutchinson Cancer Center accepting new patients
    Seattle 5809844 Washington 5815135 98109 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
ID
NCT06625775
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 392 study participants
Last Updated