Health Trials

About this trial

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 and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with malignancy within the last 2 years as specified in the protocol

Patients with untreated or unstable brain metastases

Patients with known hypersensitivity to BBO-8520 or its excipients

Patients with a known hypersensitivity to pembrolizumab or its excipients

Trial design

Treatments tested in this trial

  • BBO-8520
  • Pembrolizumab
  • BBO-10203

Treatment groups

350 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

35
Australia
Kinghorn Cancer Centre2010, DarlinghurstNew South Wales, Australia
Flinders Medical Centre5042, Bedford ParkSouth Australia, Australia
The Queen Elizabeth Hospital5011, Woodville SouthSouth Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group (PAS)3199, FrankstonVictoria, Australia

Sponsors and collaborators

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Lead sponsor

Source ClinicalTrials.gov