Exclusions encompass recent radiotherapy (<14 days), severe comorbidities (e.g., gastric ulcers, pulmonary fibrosis), uncontrolled CNS metastases, grade &ge;2 neuropathy, active infections, cardiac risks (e.g., arrhythmias, bradycardia), major surgery (<28 days), recent transfusions, or live vaccinations (<30 days). Parts B/D exclude patients contraindicated for first-line SoC. Additional investigator-assessed contraindications may apply.

Parts A and B focus on determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT102, defined as the highest dose below the level causing ≥33% dose-limiting toxicities (DLTs). Parts C and D evaluate efficacy via objective response rate (ORR) per RECIST 1.1, alongside safety assessments including DLTs, treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and lab abnormalities. Key outcomes also include pharmacokinetics (PK), immunogenicity (anti-drug antibodies), duration of response (DoR), progression-free survival (PFS), clinical benefit rate (CBR), and overall survival (OS).

Inclusion criteria require adequate hematologic (ANC ≥1.5×10⁹/L), hepatic (bilirubin ≤1.5×ULN), renal (CrCl ≥60 mL/min), and coagulation (INR ≤1.5×ULN) function, ECOG ≤1, and life expectancy ≥3 months. Parts A-D specify disease-specific eligibility: Parts A/B include advanced/metastatic pancreatic adenocarcinoma; Part C mandates prior systemic therapy; Part D aligns with Part B but excludes contraindications to first-line SoC. Female patients must adhere to contraception protocols.