Open-label Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung Cancer

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

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around

Description

Summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Official Title

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

Details

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. 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, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Pembrolizumab, BBO-8520

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically documented locally advanced and unresectable or metastatic non-small cell lung 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 1b 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

  • University of California - San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA Health - Santa Monica Cancer Care accepting new patients
    Santa Monica California 90404 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 250 study participants
Last Updated