Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma

Inclusion Criteria

• •All Parts (key criteria)
• •Hematologic: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL
• •Hepatic: Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN
• •Renal: Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula
• •Prothrombin time/international normalized ratio (INR) ≤1.5×ULN
• •Albumin ≥3.0 mg/dL
• •Proteinuria \<1 g/24 hours
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• •Estimated life expectancy ≥3 months as per investigator's assessment
• •A female patient is eligible to participate if she is not pregnant, not breastfeeding, not of childbearing potential/ agreed with contraception
• •Part A
• •Patient has advanced inoperable or metastatic disease
• •Patient has no better treatment option available
• •Measurable or non-measurable disease according to RECIST 1.1
• •Histological or cytological evidence of adenocarcinoma of pancreas that is advanced or metastatic
• •Part B (in addition to relevant A criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic (pancreas)
• •Part C (in addition to relevant A criteria)\*Must have received at least one prior systemic therapy for advanced or metastatic disease (pancreas)
• •Part D (in addition to relevant B criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic (pancreas)
• •Patient has peripheral sensory neuropathy grade ≥2
• •Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1
• •History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)
• •Bradycardia (\<50 beats per minute)
• •Family history of sudden cardiac death before age 50
• •History or family history of congenital long QT syndrome
• •Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention
• •Time since last transfusion of RBCs ≤14 days before cycle 1 day 1
• •Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions
• •Part B/D (key)
• •\*Patients with contraindications to any component of the first-line SoC treatment