A Study Testing SOT109 for the First Time in Patients, to Assess How Safe SOT109 is, How Well it … (NCT07693751) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study Testing SOT109 for the First Time in Patients, to Assess How Safe SOT109 is, How Well it Works, and How the Body Handles it in Patients With Advanced Colorectal Cancer That Can Not be Removed by Surgery or is Metastatic
United States, Moldova100 participantsStarted 2026-06-29
Plain-language summary
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.
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
. ≥18 years of age on the day of signing the ICF
. Able to understand, sign, and provide written informed consent to participate in the trial
. 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
. Estimated life expectancy ≥3 months as assessed by the investigator
. An appropriate candidate for experimental therapy as assessed by the investigator
. Agrees not to participate in other interventional clinical trial while enrolled in the present trial (with the exception of survival follow-up period)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109
Timeframe: At the end of Cycle 1 (one cycle is 21 days)
2
Part B: Optimal dose of SOT109 for subsequent clinical trials
Timeframe: Cycle 1 Day 1 up to 30 days after the last dose (each cycle is 21 days)
3
Part B: Objective Response Rate (ORR) of SOT109
Timeframe: From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 9 months
4
Part B: Duration of Response (DoR) of SOT109
Timeframe: From the date of first documented objective response until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, assessed up to approximately 9 months.
. Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula
Exclusion criteria
. Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects
. Any prior systemic therapy for metastatic cancer other than colorectal cancer; exception:
. Participants must not receive any concurrent antitumor therapy while participating in the trial. In exceptional circumstances where urgent palliative radiotherapy to symptomatic non-target lesions is clinically indicated, the case must be reviewed with the Principal Investigator (PI) and the intervention must receive prior approval from the sponsor
. Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial interventions; the full series (e.g., both doses of a two dose vaccination series) should be completed prior to dosing if feasible
. Time since last transfusion of red blood cells ≤14 days before day 1 of cycle 1
. Severe preexisting medical conditions as per judgment of the investigator
. History of interstitial pneumonitis or pulmonary fibrosis
. Symptomatic central nervous system malignancy. Participants with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days