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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 1Ages 18 Years - anyAllKestrel Therapeutics, Inc.
NCT07458347 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • KST-6051
  • Gemcitabine/nab-paclitaxel
  • Cetuximab
  • Pembrolizumab
  • mFOLFOX6
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Where

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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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