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

NCT ID: NCT05525286

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2024-12-13

Brief Summary

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.

Detailed Description

The trial will have the following parts:

• Part A: Dose escalation, first-in-human, single-agent phase 1 trial of SOT102 in advanced/metastatic pancreatic cancer patients with unmet medical need (CLDN18.2 agnostic)
• Part B : Phase 1b dose escalation combination trial of SOT102 in combination with nab-paclitaxel/gemcitabine as SoC regimen for first-line treatment of patients with advanced/metastatic pancreatic cancer (CLDN18.2 agnostic)

Once an RP2D in the respective phase 1 evaluation (Part A and Part B) has been identified, expansion parts (Part C and Part D) are planned:

• Part C : Single-agent SOT102 expansion at RP2D identified in Part A in pancreatic cancer after one or more prior systemic therapies (second+ line) for locally advanced or metastatic disease (CLDN18.2 positive)
• Part D : SOT102 in combination with nab- paclitaxel/gemcitabine for first-line treatment expansion at RP2D identified in Part B in pancreatic cancer (CLDN18.2 positive)

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg

Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.032 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Group Type: EXPERIMENTAL

SOT102

Intervention Type: DRUG

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg

Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.064 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Group Type: EXPERIMENTAL

SOT102

Intervention Type: DRUG

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg

Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.128 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Group Type: EXPERIMENTAL

SOT102

Intervention Type: DRUG

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg

Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.214 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes.

Group Type: EXPERIMENTAL

SOT102

Intervention Type: DRUG

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg

Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with 0.,32 mg/kg of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. Upon completion of the SOT102 infusion, first-line SoC treatment was administered. SoC treatment was nab-paclitaxel (125 mg/m2) given as a 30- to 40-minute infusion followed by gemcitabine (1000 mg/m2) given as a 30-minute infusion on days 1, 8, and 15. This treatment was repeated every 28 days.

Group Type: EXPERIMENTAL

SOT102

Intervention Type: DRUG

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

Interventions

SOT102

SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

Intervention Type: DRUG

Eligibility Criteria

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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOTIO Biotech a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep Tabernero, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vall d'Hebron University Hospital (HUVH)

Locations

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

Countries

United States; Belgium; Czechia; France; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-005873-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504441-31-00

Identifier Type: CTIS

Identifier Source: secondary_id

SN201

Identifier Type: -

Identifier Source: org_study_id