Phase 1 dose-escalation of oral KST-6051 for adults with KRAS‑mutant advanced solid tumors
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
This trial will give oral KST-6051 to adults with advanced KRAS‑mutant solid tumors to see if it is safe, tolerable, and how the body processes the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kestrel Therapeutics, Inc. Academic / other |
| Locations | 7 sites (Sarasota, Florida and 6 other locations) |
| Trial ID | NCT07458347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed advanced or metastatic KRAS‑mutant solid tumors, ECOG 0–1, measurable disease, adequate organ function, and disease progression after or intolerance to standard treatments are the intended candidates.
Not a fit: Patients with prior RAS/KRAS inhibitor therapy, active central nervous system metastases, inability to take oral medication, or who are pregnant or breastfeeding are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, KST-6051 could provide a new oral treatment option for patients with KRAS‑mutant advanced solid tumors who have limited approved therapies.
How similar studies have performed: Some KRAS‑targeted drugs (for example, agents targeting KRAS G12C) have shown clinical activity for specific mutations, but KST-6051 is a first‑in‑human agent and its effectiveness in people is not yet known.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Sarasota, Florida and 6 other locations
- 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)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kestrel Therapeutics, Inc.
- Email: clinicaltrials@kestreltherapeutics.com
- Phone: 617-612-6810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.