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.
≥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
Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects
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
Sequential
SOT109
Biological/VaccineSOT109 is a CDH17-directed monoclonal antibody conjugated to a linker-payload, exatecan
7
Treatment groupsSee each treatment group below.
Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109
MTD will be selected as guided by the time to-event Bayesian optimal interval (TITEBOIN) design. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
Part B: Optimal dose of SOT109 for subsequent clinical trials
Assessment of the safety and tolerability of two recommended doses under evaluation for dose optimization (RDOs) of SOT109 by evaluation of the occurrence of SOT109 related TEAEs, serious TEAEs, TEAEs leading to premature discontinuation of SOT109, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to NCI CTCAE Version 6.0
Part B: Objective Response Rate (ORR) of SOT109
Percentage of participants who achieve a Best Overall Response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Part B: Duration of Response (DoR) of SOT109
The time from the first documentation of objective response (CR or PR) to the first documented date of progressive disease (PD) according to RECIST v1.1.
Part A: Safety and Tolerability of SOT109
The occurrence of dose-limiting toxicities (DLTs), SOT109-related treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to premature discontinuation of SOT109, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) Version 6.0
Part A: Characterization of maximum concentration (Cmax)
Cmax in plasma of total antibody, conjugated antibody and free exatecan.
Part A: Characterization of time to maximum concentration (Tmax)
Time to maximum concentration of total antibody, conjugated antibody and free exatecan.
Part A: Characterization of area under the curve
Area under the concentration versus time curve calculated for total antibody, conjugated antibody and free exatecan.
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