RecruitingRecruiting
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
NCT07458347 · Kestrel Therapeutics, Inc.
In plain English
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Official title
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
About this study
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.
Eligibility 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.
Study design
Enrollment target: 145 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-21
Estimated completion: 2028-05
Last updated: 2026-05-12
Interventions
Drug: KST-6051
Primary outcomes
- • Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days) (Up to Day 21 of Treatment Cycle 1)
- • Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Up to approximately 2 years)
- • Number of Participants With Treatment-related Adverse Events (TRAEs) (Up to approximately 2 years)
Sponsor
Kestrel Therapeutics, Inc. · other
Contacts & investigators
ContactKestrel Therapeutics, Inc. · contact · clinicaltrials@kestreltherapeutics.com · 617-612-6810
All locations (7)
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Mass General Brigham Cancer Institute at Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Sidney Kimmel Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States