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NCT06343402PHASE1Recruiting

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

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

Start Date

5/22/2024

Completion Date

9/1/2031

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.

Detailed Description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI 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. The study includes dose escalation phase and dose expansion phase

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

BBO-8520

DRUG

Pembrolizumab

DRUG

BBO-10203

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Conditions

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

Locations

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama 35233

United States

University of California - San Diego Moores Cancer Center

La Jolla, California 92093

United States

University of California San Francisco

San Francisco, California 94158

United States

UCLA Health - Santa Monica Cancer Care

Santa Monica, California 90404

United States

University of Colorado Cancer Center

Aurora, Colorado 80045

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Norwalk Hospital

Norwalk, Connecticut 06850

United States

OSF Saint Francis Medical Center

Peoria, Illinois 61603

United States

University of Kansas Medical Center

Kansas City, Kansas 66205

United States

Henry Ford Cancer - Detroit

Detroit, Michigan 48282

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Perlmutter Cancer Center - NYU Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

USOR - Oncology Associates of Oregon, P.C

Eugene, Oregon 97401

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Oncology Consultants Texas Medical Center

Houston, Texas 77030

United States

USOR - Texas Oncology - (DFW) Waco

Waco, Texas 76710

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

NEXT Oncology

Fairfax, Virginia 22031

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Northwest Medical Specialties

Tacoma, Washington 98405

United States

Kinghorn Cancer Centre

Darlinghurst, New South Wales 2010

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

The Queen Elizabeth Hospital

Woodville South, South Australia 5011

Australia

Peninsula & South Eastern Hematology and Oncology Group (PAS)

Frankston, Victoria 3199

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3051

Australia

Linear Clinical Research

Nedlands, Western Australia 6009

Australia

Juravinski Cancer Centre

Hamilton, Ontario L8V 5C2

Canada

The Princess Margaret Cancer Centre

Toronto, Ontario M5G 2C4

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Rigshospitalet

Copenhagen, 2100

Denmark

START Barcelona - Hospital HM Nou Delfos

Barcelona, 08023

Spain

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Hospital Universitario Quirónsalud Madrid

Madrid, 28223

Spain