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Evaluating BBO-8520 for treating KRAS G12C non-small cell lung cancer

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

Phase 1 Interventional TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · NCT06343402

This study is testing a new drug called BBO-8520 to see if it can safely help adults with a specific type of lung cancer that has a KRAS G12C mutation, both on its own and when combined with another treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years and up
SexAll
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Industry-sponsored
Drugs / interventionspembrolizumab
Locations35 sites (Birmingham, Alabama and 34 other locations)
Trial IDNCT06343402 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BBO-8520, a direct inhibitor of KRAS G12C, both as a standalone treatment and in combination with pembrolizumab. The trial focuses on adult patients with locally advanced and unresectable or metastatic non-small cell lung cancer harboring the KRAS G12C mutation. It includes a dose escalation phase followed by a dose expansion phase to gather comprehensive data on the drug's performance.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation and an ECOG performance status of 0-1.

Not a fit: Patients with untreated brain metastases or those with a history of autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12C mutated non-small cell lung cancer.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where this trial is running

Birmingham, Alabama and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.