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NCT06917079PHASE1Recruiting

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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

Start Date

3/31/2025

Completion Date

9/1/2029

Summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Detailed Description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Life expectancy \>24 weeks * Adequate organ function Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases Other inclusion/exclusion criteria are specified in the protocol.

Interventions

DRUG

BBO-11818

DRUG

Pembrolizumab

DRUG

Platinum chemotherapy (cisplatin or carboplatin)

DRUG

Pemetrexed

DRUG

Cetuximab

DRUG

mFOLFOX6

DRUG

mFOLFOX6

DRUG

BBO-10203

DRUG

mFOLFIRINOX

DRUG

Gemcitabine

DRUG

Nab-paclitaxel

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Conditions

Non-Small Cell Lung CancerNSCLCPDAC - Pancreatic Ductal AdenocarcinomaCRC (Colorectal Cancer)Metastatic Non-Small Lung Cell CancerMetastatic Colorectal Cancer (CRC)KRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VMetastatic Pancreatic Ductal AdenocarcinomaAdvanced Lung CarcinomaSolid Tumor, Adult

Locations

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California 90025

United States

University of California Davis

Sacramento, California 95817

United States

University of California San Diego Moores Cancer Center

San Diego, California 92037

United States

University of California San Francisco Helen Diller Family Comprehensive Cancer Center

San Francisco, California 94158

United States

Yale University

New Haven, Connecticut 06510

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

OSF Healthcare Cancer Institute

Peoria, Illinois 61637

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

NYU Langone Health

New York, New York 10016

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas 75230

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia