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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. Willing and able to give written informed consent.
3. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
4. Documentation of KRAS mutation prior to the first dose of trial drug(s).
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
6. Adequate cardiovascular, hematological, liver, and renal function.
7. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

Exclusion Criteria:

1. Central nervous system (CNS) tumors or untreated or unstable metastases.
2. Inability to swallow oral medications.
3. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Other inclusion/exclusion criteria are specified in the protocol.

About the study

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.

What is being tested

KST-6051 (drug)
Gemcitabine/nab-paclitaxel (drug)
Cetuximab (drug)
Pembrolizumab (drug)
mFOLFOX6 (drug)
FOLFIRI (drug)

Sponsor: Kestrel Therapeutics, Inc. · Participants: 545 · Started: Apr 21, 2026

Contact the study team

Kestrel Therapeutics, Inc. · Phone: 617-612-6810

Official record on ClinicalTrials.gov — NCT07458347

Locations in the U.S.

California	Cedars-Sinai Medical Center, Los Angeles
Florida	Florida Cancer Specialists, Sarasota Moffitt Cancer Center, Tampa
Massachusetts	Mass General Brigham Cancer Institute at Massachusetts General Hospital, Boston
Pennsylvania	Sidney Kimmel Cancer Center, Philadelphia
Texas	The University of Texas MD Anderson Cancer Center, Houston NEXT Oncology, San Antonio
Utah	Huntsman Cancer Institute, University of Utah, Salt Lake City
Virginia	NEXT Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.