gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma
Conditions
Brief summary
Part A and B •To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line standard of care (SoC) treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested., Part C and D •To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by objective response rate
Detailed description
The occurrence of DLTs, occurrence of treatment-emergent AEs (TEAEs), SOT102- related AEs, serious AEs (SAEs), AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities, PK of total SOT102, conjugated SOT102, PNU159682, PNU-EDA, -EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G (M6), Anecdotal tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by type and CLDN18.2 expression. The number of patients with detected antibodies against any part of SOT102, Additionally for Part C & Part D DoR, PFS and clinical benefit rate per RECIST 1.1, OS Assessment of global and disease-specific QoL by patient-reported questionnaires EORTC QLQ-C30 and EORTC QLQ-STO22 for patients with gastric cancer, and EORTC QLQC30 and EORTC QLQ-PAN26 for patients with pancreatic cancer
Interventions
DRUGFolinic Acid (as Calcium Folinate) 10 mg/ml Solution for Injection
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
SOTIO Biotech a.s.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A and B •To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102 given as monotherapy and in combination with first-line standard of care (SoC) treatment. MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing DLT. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested., Part C and D •To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of DLTs, occurrence of treatment-emergent AEs (TEAEs), SOT102- related AEs, serious AEs (SAEs), AEs leading to premature discontinuation of SOT102, deaths, or clinical laboratory test abnormalities, PK of total SOT102, conjugated SOT102, PNU159682, PNU-EDA, -EDA-GGT (M4), PNU-EDA-GG (M5), and PNU-EDA-G (M6), Anecdotal tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by type and CLDN18.2 expression. The number of patients with detected antibodies against any part of SOT102, Additionally for Part C & Part D DoR, PFS and clinical benefit rate per RECIST 1.1, OS Assessment of global and disease-specific QoL by patient-reported questionnaires EORTC QLQ-C30 and EORTC QLQ-STO22 for patients with gastric cancer, and EORTC QLQC30 and EORTC QLQ-PAN26 for patients with pancreatic cancer | — |
Countries
Belgium, Czechia, France, Spain
Outcome results
None listed