Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer

a study on Lung Cancer Non-Small Cell Lung Cancer KRAS G12C Colorectal Cancer Colon Cancer Carcinoma Lung Tumor Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around

Description

Summary

A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer

Official Title

A Phase 1a/1b Open-Label Study of BBO-8520 As Monotherapy and As Part of Combination Therapy in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer and Colorectal Cancer - the ONKORAS-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-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer and colorectal cancer. The study includes dose escalation phase and dose expansion phase

Keywords

Non-small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, NSCLC, KRAS G12C, Metastatic Lung Cancer, Advanced Lung Carcinoma, Colorectal Cancer, Metastatic Colorectal Cancer, CRC, Advanced Colorectal Carcinoma, Metastatic Colon Cancer, Colon Cancer, Carcinoma, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Colonic Neoplasms, Pembrolizumab, BBO-8520

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically documented locally advanced or metastatic non-small cell lung cancer or colorectal cancer with a KRAS G12C mutation
  • Measurable disease by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

You CAN'T join if...

  • Patients with malignancy within the last 2 years as specified in the protocol
  • Patients with untreated brain metastases
  • Patients with known hypersensitivity to BBO-8520 or its excipients
  • For Cohorts 2a and 2b:
  • Patients with a known hypersensitivity to pembrolizumab or its excipients
  • Patients with active autoimmune disease of history of autoimmune disease that might recur
  • Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Other inclusion/exclusion criteria may apply

Locations

  • UCLA Health - Santa Monica Cancer Care accepting new patients
    Santa Monica California 90404 United States
  • University of California - San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
ID
NCT06343402
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 229 study participants
Last Updated