A First-in-human Phase 1/2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer
SOTIO Biotech a.s.
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.
Description
The trial will consist of the following parts: * Part A: a multinational, multicenter, open-label, TITE-BOIN-guided trial to determine the MTD and RP2Ds, to evaluate the safety, PK, and preliminary efficacy of escalating doses of SOT109 in participants with advanced unresectable or metastatic colorectal cancer who have received and/or have been determined to be intolerant of all standard of care therapy known to confer clinical benefit. * Part B: This is a randomized, multinational, multicenter, open-label dose optimization trial evaluating the two recommended doses for optimization (RDOs) id…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 whil…
Interventions
- BiologicalSOT109
SOT109 is a CDH17-directed monoclonal antibody conjugated to a linker-payload, exatecan
Locations (3)
- NEXT HoustonHouston, Texas
- NEXT VirginiaFaifax, Virginia
- Arensia Exploratory Medicine Research Unit, Institute of OncologyChisinau