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

NCT05525286 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: SN2012021-005873-252023-504441-31-00
• Study Type: interventional
• Target: 31
• Locations: 5 countries
• Sites: 8

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Advanced Cancer; Metastatic Cancer

Outcome Measures

Primary Outcomes (2)

• Parts A and B: The Definition of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of SOT102 Given as Monotherapy and in Combination With First-line SoC Treatment

  MTD is defined as the highest dose level tested below the dose level associated with ≥33% of dose-limiting toxicity (DLT)-evaluable patients experiencing a DLT. The RP2D will be selected based on evaluation of the totality of all data. The trial was halted early due to safety signals not initially deemed DLTs that were seen across different dose levels. After a protocol amendment formally defined this signal as a DLT, the trial was restarted, but the same safety signal reappeared. Following a review by the independent Dose Escalation Committee, the trial was terminated.

  Through Cycles 1-2 (28 days)

• Parts C and D: The Assessment of the Efficacy of SOT102 in Monotherapy and in Combination With First-line SoC Treatment

  Efficacy is determined by objective response rate (ORR) determined according to RECIST 1.1 criteria

  From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, to be assessed up to approximately 4 years

Secondary Outcomes (17)

• Parts A and B (Monotherapy and Combination With SoC): Number of Participants With DLTs

  Through Cycles 1-2 (28 days)

• Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Treatment-emergent AEs (TEAEs)

  Day 1 up to approximately 2 years and 8.5 months

• Parts A and B (Monotherapy and Combination With SoC): Number of Participants With SOT102-related AEs

  Day 1 up to approximately 2 years and 8.5 months

• Part B (Combination With SoC): Number of Participants With SoC-related AEs

  Day 1 up to approximately 2 years and 8.5 months

• Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Serious AEs (SAEs)

  Day 1 up to approximately 2 years and 8.5 months

Study Arms (5)

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

EXPERIMENTAL

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.

Drug: SOT102

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

EXPERIMENTAL

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.

Drug: SOT102

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

EXPERIMENTAL

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.

Drug: SOT102

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

EXPERIMENTAL

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.

Drug: SOT102

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

EXPERIMENTAL

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.

Drug: SOT102

Interventions

SOT102 DRUG

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

SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg; SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg; SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg; SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg; SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)

Sponsors & Collaborators

• SOTIO Biotech a.s.: lead

Study Sites (8)

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Institut Jules Bordet

Brussels, Belgium

Location

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Masarykův Onkologický Ústav

Brno, Czechia

Location

Institut Gustave Roussy

Paris, France

Location

VHIO - Vall d'Hebron Institut d'Oncologia

Barcelona, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Richard Kapsa
• Organization: SOTIO Biotech a.s.

kapsa@sotio.com

(+420) 2241 74448

Study Officials

• Josep Tabernero, M.D., Ph.D.

  Vall d'Hebron University Hospital (HUVH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SN201 is a multi-modular clinical trial in patients with pancreatic adenocarcinoma.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: September 1, 2022
• Study Start: March 31, 2022
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); US (2); FR (1); CZ (1); ES (2)