NCT06343402RecruitingPhase 1
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C 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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 22 May 2024
- Primary completion date
- 30 Apr 2031
- Lead sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Diseases
- Lung cancer
- NCT number
- NCT06343402
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 350
- From 22 May 2024 to the primary completion date, 30 Apr 2031
- 38 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Patients with untreated or unstable brain metastases
- For Cohorts 1b and 2b:
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Recruiting |
| Kinghorn Cancer Centre Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Peninsula & South Eastern Hematology and Oncology Group (PAS) Coordinator of this site? Confirm its status | Frankston | Australia | Recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| START Barcelona Hospital HM Nou Delfos Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Vall d'Hebron University Hospital Coordinator of this site? Confirm its status | Horta-Guinardó | Spain | Recruiting |
| Hospital Universitario Quirónsalud Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| START Madrid / Hospital Universitario Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University of Colorado Cancer Center Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| O'Neal Comprehensive Cancer Center at UAB Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Henry Ford Cancer- Detroit Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| USOR - Oncology Associates of Oregon, P.C Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Oncology Consultants Texas Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Perlmutter Cancer Center, NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Norwalk Hospital Coordinator of this site? Confirm its status | Norwalk | United States | Recruiting |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| UCLA Health - Santa Monica Cancer Care Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Northwest Medical Specialties Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| USOR - Texas Oncology - (DFW) Waco Coordinator of this site? Confirm its status | Waco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.