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

NCT06343402 · tracked via the Priya Life Science Canada tracker

Sponsor

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

Phase

Phase 1

Started

2024-05-22

Last updated

2026-09-03

Condition(s) studied

Non-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma

Investigational drug(s) / intervention(s)

BBO-8520Pembrolizumab →BBO-10203 →

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Adverse Events — approximately 3 years
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Dose-limiting toxicities (DLTs) — approximately 3 years
Number of participants with dose limiting toxicities

Trial sites (38)

Facility	City	Region	Status
O'Neal Comprehensive Cancer Center at UAB	Birmingham	Alabama	Recruiting
University of California - San Diego Moores Cancer Center	La Jolla	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
UCLA Health - Santa Monica Cancer Care	Santa Monica	California	Recruiting
University of Colorado Cancer Center	Aurora	Colorado	Recruiting
Yale Cancer Center	New Haven	Connecticut	Recruiting
Norwalk Hospital	Norwalk	Connecticut	Recruiting
OSF Saint Francis Medical Center	Peoria	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center	Baltimore	Maryland	Recruiting
Henry Ford Cancer - Detroit	Detroit	Michigan	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Recruiting
Perlmutter Cancer Center - NYU Langone Health	New York	New York	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
USOR - Oncology Associates of Oregon, P.C	Eugene	Oregon	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
Oncology Consultants Texas Medical Center	Houston	Texas	Recruiting
USOR - Texas Oncology - (DFW) Waco	Waco	Texas	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting
NEXT Oncology	Fairfax	Virginia	Recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	Recruiting
Northwest Medical Specialties	Tacoma	Washington	Recruiting
Kinghorn Cancer Centre	Darlinghurst	New South Wales	Recruiting
Flinders Medical Centre	Bedford Park	South Australia	Recruiting
The Queen Elizabeth Hospital	Woodville South	South Australia	Recruiting
Peninsula & South Eastern Hematology and Oncology Group (PAS)	Frankston	Victoria	Recruiting
Peter MacCallum Cancer Centre	Melbourne	Victoria	Recruiting
Linear Clinical Research	Nedlands	Western Australia	Recruiting
Cross Cancer Institute	Edmonton	Alberta	Recruiting
Juravinski Cancer Centre	Hamilton	Ontario	Recruiting
The Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
Jewish General Hospital	Montreal	Quebec	Recruiting
Rigshospitalet	Copenhagen	Denmark	Recruiting
Vall d'Hebron University Hospital	Horta-Guinardó	Barcelona	Recruiting
START Barcelona - Hospital HM Nou Delfos	Barcelona	Spain	Recruiting
START Madrid - Hospital Universitario Fundación Jiménez Díaz	Madrid	Spain	Recruiting
Hospital Universitario Quirónsalud Madrid	Madrid	Spain	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06343402 on ClinicalTrials.gov ↗ ← All trials in Canada