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

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer

In brief

This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (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 or metastatic pancreatic adenocarcinoma.

Key facts

Study ID

NCT05525286

Run by

SOTIO Biotech a.s.

People needed

31

Starts

2022-03-31

Expected to finish

2024-12-13

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• All Parts (key criteria)
• 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
• 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

Where it is running

• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• Institut Jules Bordet — Brussels, Belgium
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium
• Masarykův Onkologický Ústav — Brno, Czechia
• Institut Gustave Roussy — Paris, France
• VHIO - Vall d'Hebron Institut d'Oncologia — Barcelona, Spain
• Hospital Universitario HM Sanchinarro — Madrid, Spain

Full record on ClinicalTrials.gov

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