Opening soonPhase 2Randomised
| Registry number | NCT07693751 |
|---|---|
| Recruitment | Opening soon |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | SOTIO Biotech a.s. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological SOT109
What it is measuring
Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT109, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- HER2 positive
- dMMR / MSI-H
- 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. ≥18 years of age on the day of signing the ICF
2. Able to understand, sign, and provide written informed consent to participate in the trial
3. Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1. Patients with ECOG performance score 2 will be discussed with the sponsor's medical monitor to be agreed for inclusion
4. Estimated life expectancy ≥3 months as assessed by the investigator
5. An appropriate candidate for experimental therapy as assessed by the investigator
6. Agrees not to participate in other interventional clinical trial while enrolled in the present trial (with the exception of survival follow-up period)
7. Absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL
8. Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula
9. Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN
- Participants with a documented history of Gilbert syndrome may be eligible if:
- Total bilirubin is ≤2.0 × ULN,
- Direct (conjugated) bilirubin is within normal limits (≤ULN), and
- There is no evidence of active liver disease, clinically significant hepatic impairment, hemolysis, or biliary obstruction, as determined by the investigator
10.
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 3 sites. Listed in: Moldova, 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 NCT07693751, registered by SOTIO Biotech a.s. 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.