Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether KQB368, taken by mouth on its own, can shrink advanced solid tumours. The trial will also examine how the drug moves through the body and identify a dose that can be given safely.
Because there is no comparison treatment, the trial is mainly designed to find a tolerable dose and look for signs of tumour shrinkage, rather than to show that KQB368 helps people live longer or keeps cancer from growing longer than standard treatment.
Worth knowing: This is a small, non-randomised phase 1 trial, so its main purpose is safety and dosing, not proof of 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 | NCT07542704 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 48 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Kumquat Biosciences Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug KQB368
What it is measuring
Primary Objective
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 goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
* What is the safe dose of KQB368 as a monotherapy?
* Does KQB368 decrease the size of the tumor?
* What happens to KQB368 in the body?Participants will:
* Take KQB368 orally daily in 21-day cycles
* Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after thatWritten by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12C
- Other codon
- Metastatic
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
- Histologically confirmed diagnosis of a solid tumor
- Malignancy with either a KRAS G12C or KRAS G12S mutation
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST v1.1
- Must be able to swallow with no GI condition that prevents absorption
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 14 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 NCT07542704, registered by Kumquat Biosciences 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.