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Taking people in United StatesPhase 1

Testing KST-6051 in advanced cancers with a KRAS mutation

Tests the safety of KST-6051 in adults with KRAS-mutant advanced solid tumors.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Boston, Fairfax, Houston, Los Angeles, Philadelphia, Salt Lake City, San Antonio, Sarasota, and Tampa, United StatesSee the 9 sites
Phase
Phase 1

Where in United States

  • Mass General Brigham Cancer Institute at Massachusetts General HospitalBoston, United StatesTaking people
  • NEXT VirginiaFairfax, United StatesTaking people
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
  • Sidney Kimmel Cancer CenterPhiladelphia, United StatesTaking people
  • Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
  • NEXT OncologySan Antonio, United StatesTaking people
  • Florida Cancer SpecialistsSarasota, United StatesTaking people
  • Moffitt Cancer CenterTampa, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Kestrel Therapeutics, Inc.
Trial code
NCT07458347
Record updated
15 October 2026
Original description
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.Read full original descriptionShow less

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

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.

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

Exclusion: Inability to swallow oral medications; Central nervous system (CNS) tumors or untreated or unstable metastases; 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.

ClinicalTrials.gov NCT07458347