Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether KST-6051, an oral drug, can be given safely to people with advanced or metastatic solid tumours carrying certain KRAS mutations. The trial will help establish doses that patients can tolerate.
The aim is to find a usable dose for further testing in cancers driven by these KRAS changes; in this first phase, the key measure is dose-limiting toxicity during the first 21-day treatment cycle, not whether patients live longer or their cancer stays controlled.
Worth knowing: This is a small, non-randomised Phase 1 trial focused on safety and tolerability, with no comparison group or evidence yet of treatment benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07458347 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 545 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Kestrel Therapeutics, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug KST-6051
- Drug Gemcitabine/nab-paclitaxel
- Drug Cetuximab
- Drug Pembrolizumab
- Drug mFOLFOX6
- Drug FOLFIRI
- Drug Pemetrexed
- Drug Carboplatin
What it is measuring
Dose Escalation Cohorts: Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
6. Adequate cardiovascular, hematological, liver, and renal function.
7. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Exclusion Criteria
1. Central nervous system (CNS) tumors or untreated or unstable metastases.
2. Inability to swallow oral medications.
3. 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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 9 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07458347, registered by Kestrel Therapeutics, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.