A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirst… (NCT07458347) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
United States145 participantsStarted 2026-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since KST-6051 is in Phase 1 and the trial is primarily measuring side effects and safe dosing rather than whether it shrinks tumors, what does that mean for weighing the potential risks against any possible benefit for my specific situation?
2My cancer has a KRAS mutation — could you tell me which specific KRAS variant I have, and does it matter which variant I carry when it comes to whether this drug might be relevant for me to discuss with the trial team?
3Because this is a dose-escalation study where researchers are still figuring out the right dose, could I potentially be in a cohort receiving a lower dose that may not be therapeutically active, and how does that factor into your thinking about whether this is the right path right now?
4Are there already approved KRAS-targeted therapies or standard treatment options — like chemotherapy regimens or existing KRAS G12C inhibitors — that we should consider first before exploring an early-phase trial like this one?
5What would the treatment schedule and monitoring look like in practice — given that each cycle is 21 days and the trial is closely tracking adverse events — and would the time commitment and potential side effects be manageable alongside my current health status?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
Timeframe: Up to Day 21 of Treatment Cycle 1
2
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 2 years
3
Number of Participants With Treatment-related Adverse Events (TRAEs)