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RECRUITING
NCT07458347
PHASE1

A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

Sponsor: Kestrel Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.

Official title: A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

545

Start Date

2026-04-21

Completion Date

2029-04

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

KST-6051

KST-6051 will be administered orally as a tablet.

DRUG

Gemcitabine/nab-paclitaxel

Gemcitabine/nab-paclitaxel will be administered intravenously (IV).

DRUG

Cetuximab

Cetuximab will be administered IV.

DRUG

Pembrolizumab

Pembrolizumab will be administered IV.

DRUG

mFOLFOX6

mFOLFOX6 will be administered IV.

DRUG

FOLFIRI

FOLFIRI will be administered IV.

DRUG

Pemetrexed

Pemetrexed will be administered IV.

DRUG

Carboplatin

Carboplatin will be administered IV.

Locations (9)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mass General Brigham Cancer Institute at Massachusetts General Hospital

Boston, Massachusetts, United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States