Health Trials

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

ConditionsNon-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

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.

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov