Phase 1 KST-6051 for Advanced KRAS-Mutant Solid Tumors

This study is testing a new oral medication called KST-6051 for people with advanced solid tumors that have a specific genetic change called a KRAS mutation. This includes certain types of lung, pancreatic, and colorectal cancers, as well as other solid tumors. You might be able to join if your cancer has progressed after standard treatments or if you couldn't tolerate those treatments. The main goal is to find out if KST-6051 is safe and tolerable, and to see what dose works best. Researchers will also look for early signs that the treatment is working. The study plans to enroll 145 participants, but the current enrollment status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving KST-6051. It will involve a dose escalation phase, where different groups of participants will receive increasing doses of KST-6051.
What's involved
Participants will take KST-6051 orally as a tablet. You can stay in the trial as long as you benefit from the treatment and can tolerate it.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07458347

A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kestrel Therapeutics, Inc.
~145 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:KST-6051

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
Measured over Up to Day 21 of Treatment Cycle 1
+2 more outcomes measured
KRAS-mutant Non-small Cell Lung Cancer (NSCLC)
KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)
KRAS-mutant Colorectal Cancer (CRC)
Other KRAS-mutant Solid Tumors
9 sites across 7 states
Florida2
Texas2
California1
Massachusetts1
Pennsylvania1
Utah1
Virginia1

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  • 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

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.

  • Number of Participants With Treatment-related Adverse Events (TRAEs)Up to approximately 2 years

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.