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
Principal Investigator
by Edward B. Garon, MD, MS (ucla)
Headshot of Edward B. Garon
Edward B. Garon

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

Lead Scientist at University of California Health

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