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RECRUITING
NCT06917079
PHASE1

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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

View on ClinicalTrials.gov

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.

Official title: A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2025-03-31

Completion Date

2029-09

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

BBO-11818

Participants will receive assigned dose of BBO-11818 orally (PO)

DRUG

Pembrolizumab

Patients will receive IV pembrolizumab

DRUG

Platinum chemotherapy (cisplatin or carboplatin)

Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

DRUG

Pemetrexed

Patients will receive IV pemetrexed

DRUG

Cetuximab

Patients will receive IV cetuximab

DRUG

FOLFOX

Patients will receive IV FOLFOX

DRUG

NALIRIFOX

Patients will receive IV NALIRIFOX

DRUG

Gemcitabine

Patients will receive IV Gemcitabine

DRUG

Nab-paclitaxel

Patients will receive IV Nab-Paclitaxel

Locations (11)

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States

University of California San Diego Moores Cancer Center

San Diego, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

NYU Langone Health

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States