RecruitingPhase 1NCT07458347
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
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
Sponsor
Kestrel Therapeutics, Inc.
Enrollment
145 participants
Start Date
Apr 21, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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).
- Progressed on or intolerant to standard treatment(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 Criteria4
- Previous or current treatment with RAS or KRAS inhibitors.
- Central nervous system (CNS) tumors or metastases.
- Inability to swallow oral medications.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
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Interventions
DRUGKST-6051
KST-6051 will be administered orally as a tablet.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07458347