RecruitingPhase 1NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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


Sponsor

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

Enrollment

387 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called BBO-11818 in adults with advanced cancers that carry a specific KRAS mutation — a genetic change found in several common cancers including lung, pancreatic, and colorectal cancer. The study aims to determine the right dose and early signs of effectiveness. **You may be eligible if...** - You are an adult with confirmed advanced or metastatic lung cancer (NSCLC), pancreatic cancer, colorectal cancer, or another solid tumor - Your tumor has a KRAS G12A, G12C, G12D, G12S, or G12V mutation - You have measurable disease on imaging - Your performance status is good (ECOG 0-1) **You may NOT be eligible if...** - You have had another malignancy within the last 2 years (certain exceptions may apply) - You have untreated brain metastases - You have a known allergy to BBO-11818 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBBO-11818

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

DRUGPembrolizumab

Patients will receive IV pembrolizumab

DRUGPlatinum chemotherapy (cisplatin or carboplatin)

Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

DRUGPemetrexed

Patients will receive IV pemetrexed

DRUGCetuximab

Patients will receive IV cetuximab

DRUGFOLFOX

Patients will receive IV FOLFOX

DRUGNALIRIFOX

Patients will receive IV NALIRIFOX

DRUGGemcitabine

Patients will receive IV Gemcitabine

DRUGNab-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06917079


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