Recruiting

Phase 1

BBO-8520Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

Sponsor:

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Code:

NCT06343402

Conditions

Non-small Cell Lung Cancer

Metastatic Non-Small Cell Lung Cancer

NSCLC

KRAS G12C

Metastatic Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BBO-8520

Pembrolizumab

BBO-10203

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer

Metastatic Non-Small Cell Lung Cancer

NSCLC

KRAS G12C

Metastatic Lung Cancer

Study ID

NCT06343402

Start date

May 22, 2024

Status verified date

Sep, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

Patients with malignancy within the last 2 years as specified in the protocol
Patients with untreated or unstable 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

Other inclusion/exclusion criteria may apply

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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)

experimental: Cohort 2a - Dose Expansion Monotherapy

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy

experimental: 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)

experimental: Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination Therapy

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)

experimental: Cohort 1b - Dose Expansion Doublet Combination Therapy

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)

experimental: Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination Therapy

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)

experimental: Cohort 1b - Dose Expansion Triplet Combination Therapy

Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)

Interventions

BBO-8520

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Pembrolizumab

Patients will receive IV pembrolizumab

BBO-10203

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Primary outcome measure

Adverse Events [ Time Frame: approximately 3 years ]
Dose-limiting toxicities (DLTs) [ Time Frame: approximately 3 years ]

Central Contacts and Locations

Central contacts

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

650-405-8440 onkoras-101ct.gov@bridgebiooncology.com

Locations

O'Neal Comprehensive Cancer Center at UAB

Recruiting

Birmingham, Alabama, United States, 35233

University of California - San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

UCLA Health - Santa Monica Cancer Care

Recruiting

Santa Monica, California, United States, 90404

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Norwalk Hospital

Recruiting

Norwalk, Connecticut, United States, 06850

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61603

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66205

University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Henry Ford Cancer - Detroit

Recruiting

Detroit, Michigan, United States, 48282

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Perlmutter Cancer Center - NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

USOR - Oncology Associates of Oregon, P.C

Recruiting

Eugene, Oregon, United States, 97401

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Oncology Consultants Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

USOR - Texas Oncology - (DFW) Waco

Recruiting

Waco, Texas, United States, 76710

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

The Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) on 2026-09-03.