Phase 1 dose-escalation of oral KST-6051 for adults with KRAS‑mutant advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label, multicenter phase 1 trial uses a dose-escalation design to find safe and tolerable dose levels of orally administered KST-6051. Adults with advanced or metastatic KRAS‑mutant solid tumors (including NSCLC, PDAC, and CRC) whose disease progressed after or who cannot tolerate standard therapies are eligible. The study will collect safety data, pharmacokinetics, pharmacodynamics, and biomarker information while monitoring tumor response. Participants who benefit and can tolerate treatment may continue on study therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Mass General Brigham Cancer Institute at Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Sidney Kimmel Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Kestrel Therapeutics, Inc.
• Email: clinicaltrials@kestreltherapeutics.com
• Phone: 617-612-6810

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating FMC-376 for advanced solid tumors with KRAS G12C mutations

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.