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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

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaRecruiting
Kinghorn Cancer Centre
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DarlinghurstAustraliaRecruiting
Peninsula & South Eastern Hematology and Oncology Group (PAS)
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FrankstonAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
Linear Clinical Research
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NedlandsAustraliaRecruiting
The Queen Elizabeth Hospital
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Woodville SouthAustraliaRecruiting
Cross Cancer Institute
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EdmontonCanadaRecruiting
Juravinski Cancer Centre
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HamiltonCanadaRecruiting
Jewish General Hospital
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MontrealCanadaRecruiting
The Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Rigshospitalet
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CopenhagenDenmarkRecruiting
START Barcelona Hospital HM Nou Delfos
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BarcelonaSpainRecruiting
Vall d'Hebron University Hospital
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Horta-GuinardóSpainRecruiting
Hospital Universitario Quirónsalud Madrid
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MadridSpainRecruiting
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
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MadridSpainRecruiting
University of Colorado Cancer Center
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AuroraUnited StatesRecruiting
University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center
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BaltimoreUnited StatesRecruiting
O'Neal Comprehensive Cancer Center at UAB
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BirminghamUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Henry Ford Cancer- Detroit
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DetroitUnited StatesRecruiting
USOR - Oncology Associates of Oregon, P.C
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EugeneUnited StatesRecruiting
NEXT Oncology
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FairfaxUnited StatesRecruiting
Oncology Consultants Texas Medical Center
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HoustonUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
University of California San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Yale Cancer Center
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New HavenUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Perlmutter Cancer Center, NYU Langone Health
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New YorkUnited StatesRecruiting
Norwalk Hospital
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NorwalkUnited StatesRecruiting
OSF Saint Francis Medical Center
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PeoriaUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
UCLA Health - Santa Monica Cancer Care
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Santa MonicaUnited StatesRecruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
Northwest Medical Specialties
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TacomaUnited StatesRecruiting
USOR - Texas Oncology - (DFW) Waco
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WacoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.