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
- Copenhagen, DenmarkSee the site
- Phase
- Phase 1
Where in Denmark
- RigshospitaletCopenhagen, DenmarkTaking 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?
Trial 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:.