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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (mFOLFOX6 with nivolumab and nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOTIO Biotech

Criteria

Inclusion Criteria:

All Parts (key criteria)

• Hematologic: Absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL (time since last transfusion ≥14 days)

• 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 the stomach or GEJ or pancreas that is advanced or metastatic

Part B (in addition to relevant A criteria)

• Histological or cytological evidence of adenocarcinoma of the stomach or GEJ that is advanced or metastatic

• Must have HER2-negative tumors (gastric)

• 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 two prior systemic therapies for advanced or metastatic disease. If HER2 overexpression: must have received anti-HER2 therapy (gastric)

• 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 stomach or GEJ that is advanced inoperable or metastatic

• Must have HER2-negative tumors (gastric)

• Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic (pancreas)

Exclusion Criteria:

All Parts (key criteria)

• Prior therapy with any agent directed at CLDN18.2

• Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects

• Severe preexisting medical conditions as per judgement of the investigator (e.g., active gastric or GEJ ulcer with or without bleeding, complete or incomplete gastric outlet syndrome with persistent or repetitive bleeding)

• History of interstitial pneumonitis or pulmonary fibrosis

• Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.

• Patient has peripheral sensory neuropathy grade ≥2

• Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1

• Known history of HIV infection or known active hepatitis B or hepatitis C

• 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

Part B/D (key)

• Patients with contraindications to any component of the first-line SoC treatment

• Dihydropyrimidine dehydrogenase (DPD) deficiency (gastric)