Tests BBO-8520 alone or with other drugs in lung cancer with KRAS G12C
Tests BBO-8520, alone or combined, in adults with advanced KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Key facts
- Where
- Bedford Park, Darlinghurst, Frankston, Melbourne, Nedlands, and Woodville South, AustraliaSee the 6 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (non-small cell) that carries a KRAS G12C change. It tests BBO-8520 alone and with other drugs.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Non-small cell lung cancer that has spread locally and cannot be removed by surgery, or has spread to other parts of the body. The cancer must be measurable by RECIST v1.1.
- Biomarker or test result
- The cancer must have a KRAS G12C mutation.
Main reasons for not taking part
- Another cancer within the last 2 years, as set out in the protocol
- Brain metastases that are untreated or unstable
- Known allergy to BBO-8520 or its excipients
- For the pembrolizumab cohorts: allergy to pembrolizumab, or an autoimmune disease that might return
- For the pembrolizumab cohorts: current or past lung inflammation (interstitial lung disease or pneumonitis) that needed steroids
Read by machine on 9 November 2026.
Where in Australia
- Flinders Medical CentreBedford Park, AustraliaTaking people
- Kinghorn Cancer CentreDarlinghurst, AustraliaTaking people
- Peninsula & South Eastern Hematology and Oncology Group (PAS)Frankston, AustraliaTaking people
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
- Linear Clinical ResearchNedlands, AustraliaTaking people
- The Queen Elizabeth HospitalWoodville South, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Trial code
- NCT06343402
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
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 known hypersensitivity to BBO-8520 or its excipients; 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; Patients with untreated or unstable brain metastases; For Cohorts 1b and 2b:.