SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, 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 SOT106, 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 and body weight of ≥30 kg on the day of signing the prescreening ICF
In the US after dose levels 1 and 2 have been declared safe (following DEC review of the safety and PK data from the first two adult dose levels), participants aged ≥12 years on the day of signing the prescreening ICF may be enrolled from dose level 3 onwards
In the EU participants aged ≥12 years on the day of signing the prescreening ICF may be enrolled in backfilling cohorts once dose level 3 has been cleared in adults, following DEC review of safety, PK and efficacy data. In addition, preliminary signs of efficacy should have been observed in adults, based on the investigator's judgment.
Participants ≥ 18 years of age are able to understand, sign, and provide written informed consent to participate in the trial. For participants under 18 years of age, their legal representative must provide a written informed consent. Participants aged 12 to 17 must be willing and able to provide a written assent.
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 osteosarcoma and STS; exception: stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer; radiochemotherapy is allowed if such treatment is completed at least 4 weeks prior to day 1 of cycle 1; participants must have recovered to grade ≤1 from all side effects (exception: alopecia). 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 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
SOT106
Biological/VaccineSOT106 is a LRRC15-directed monoclonal antibody conjugated to a linker-payload, Monomethyl auristatin E
6
Treatment groupsSee each treatment group below.
Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT106
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 SOT106 for subsequent clinical trials
Assessment of the safety and tolerability of two recommended doses under evaluation for dose optimization (RDOs) of SOT106 by evaluation of the occurrence of SOT106 related TEAEs, serious TEAEs, TEAEs leading to premature discontinuation of SOT106, 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 SOT106
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 SOT106
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 SOT106
The occurrence of dose-limiting toxicities (DLTs), SOT106-related treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to premature discontinuation of SOT106, 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 MMAE
Part A: Characterization of time to maximum concentration (Tmax)
Time to maximum concentration of total antibody, conjugated antibody and free MMAE.
Part A: Characterization of area under the curve
Area under the concentration versus time curve calculated for total antibody, conjugated antibody and free MMAE.
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