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Study of BBO-8520 for KRAS G12C Non-Small Cell Lung Cancer

This study is testing a new drug called BBO-8520, alone and in combination with pembrolizumab and BBO-10203, for adults with non-small cell lung cancer that has spread (metastatic) and has a specific genetic change called KRAS G12C. BBO-8520 works by targeting the KRAS G12C protein. The main goals are to understand how safe these treatments are and to see if they cause any serious side effects. Researchers will also look at how well the treatments work against the cancer. You might be able to join if you are an adult with this type of lung cancer, have measurable disease, and a good performance status (meaning you can do most daily activities). The study is currently recruiting about 350 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to evaluate the safety and effectiveness of BBO-8520, alone and in combination with other drugs, in about 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events and dose-limiting toxicities will be measured for approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06343402

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
~350 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:BBO-8520PembrolizumabBBO-10203

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over approximately 3 years
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
NSCLC
KRAS G12C
Metastatic Lung Cancer
Advanced Lung Carcinoma

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRas

Where it's being run

35 sites across 23 states
California3
New York3
Spain3
Connecticut2
Texas2
Washington2
South Australia2
Victoria2

Who to contact

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
[email protected]
650-405-8440
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse Eventsapproximately 3 years

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

  • Dose-limiting toxicities (DLTs)approximately 3 years

    Number of participants with dose limiting toxicities