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RecruitingInterventionalPhase 1

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

NCT ID: NCT07458347Sponsor: Kestrel Therapeutics, Inc.Last updated: 2026-06-15

Summary

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

Detailed description

This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and preliminary activity of orally administered KST-6051. The trial seeks to enroll adults with advanced or metastatic KRAS mutant solid tumors including but not limited to pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose cancers have progressed after prior therapy or in whom standard therapy was not tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051 will be given in subsequent groups of participants. Participants can stay in the trial as long as they benefit from the treatment and can tolerate it.

Arms & interventions

  • DrugKST-6051

    KST-6051 will be administered orally as a tablet.

Outcome measures

Primary

  • Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)

    Time frame: Up to Day 21 of Treatment Cycle 1

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.

    Time frame: Up to approximately 2 years

  • Number of Participants With Treatment-related Adverse Events (TRAEs)

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.

    Time frame: Up to approximately 2 years

Secondary

  • Maximum Observed Blood Concentration (Cmax) of KST-6051

    Time frame: Up to Week 6

  • Time to Achieve Cmax (Tmax) of KST-6051

    Time frame: Up to Week 6

  • Half-life (t1/2) of KST-6051

    Time frame: Up to Week 6

  • Area Under the Blood Concentration-time Curve (AUC) of KST-6051

    Time frame: Up to Week 6

  • Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  • Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

  • Duration of Overall Response (DOR)

    Time frame: Up to approximately 2 years

  • Progression-free Survival (PFS)

    Time frame: Up to approximately 2 years

  • Duration of Stable Disease

    Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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. Progressed on or intolerant to standard treatment(s). 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 7. Adequate cardiovascular, hematological, liver, and renal function. 8. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1). Exclusion Criteria: 1. Previous or current treatment with RAS or KRAS inhibitors. 2. Central nervous system (CNS) tumors or metastases. 3. Inability to swallow oral medications. 4. 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.

Study locations (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34232

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Mass General Brigham Cancer Institute at Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

NEXT Oncology

San Antonio, Texas, 78229

Recruiting

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation | Cancerify