Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
NCT ID: NCT06343402
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2024-05-22
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1a - Dose Escalation/Dose Finding Monotherapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Pembrolizumab
Patients will receive IV pembrolizumab
Cohort 2a - Dose Expansion Monotherapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Cohort 2b - Dose Expansion Combination Therapy
Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Pembrolizumab
Patients will receive IV pembrolizumab
Interventions
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BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Pembrolizumab
Patients will receive IV pembrolizumab
Eligibility Criteria
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Inclusion Criteria
* Measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion Criteria
* Patients with untreated 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
18 Years
ALL
No
Sponsors
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TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
INDUSTRY
Responsible Party
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Locations
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University of California - San Diego Moores Cancer Center
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Perlmutter Cancer Center - NYU Langone Health
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Oncology
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group (PAS)
Frankston, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Role: CONTACT
Phone: 650-391-9740
Email: [email protected]
Other Identifiers
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ONKORAS-101
Identifier Type: OTHER
Identifier Source: secondary_id
TBBO8520-101
Identifier Type: -
Identifier Source: org_study_id