Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01)

A Multicentric Phase 1/2 Trial to Evaluate the Safety and Efficacy of SOT102 as Monotherapy and in Combination With Standard of Care Treatment in Patients With Gastric and Pancreatic Adenocarcinoma

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: SOT102

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)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Institut Jules Bordet
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
• Czechia
  • Brno, Czechia
    • Masarykuv onkologicky ustav
• France
  • Paris, France
    • Institut Gustave Roussy
• Spain
  • Barcelona, Spain
    • VHIO - Vall d'Hebron Institut d'Oncologia
  • Madrid, Spain
    • Hospital Universitario HM Sanchinarro
• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine in St. Louis
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: SOT102; SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.
Experimental: 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.	Drug: SOT102; SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.
Experimental: 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.	Drug: SOT102; SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.
Experimental: 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.	Drug: SOT102; SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.
Experimental: 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.	Drug: SOT102; SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With DLTs	Adverse events (AEs) graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 considered DLTs: All grade 5 events not clearly related to disease progression or any other causes; Any grade 3 or higher non-hematologic toxicity regardless of duration; Grade 2 or higher serum creatinine elevation; Hy's law cases; Any grade 2 pneumonitis that does not resolve to grade 1 within 3 days of the initiation of maximal supportive care; Recurrent grade 2 pneumonitis; Grade 2 or higher proteinuria; Grade 4 neutropenia lasting more than 7 days; Febrile neutropenia; Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. AEs NOT considered DLTs: Grade 3 nausea, vomiting, or diarrhea that can be controlled within 72 hours; Grade 3 fatigue less than 5 days; Grade 3 or higher correctable electrolyte abnormalities that last less than 72 hours and not associated with clinical complications; Grade 3 or higher amylase or lipase	Through Cycles 1-2 (28 days)
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Treatment-emergent AEs (TEAEs)	A TEAE is defined as an AE that: emerges during SOT102 treatment, having been absent at the time of pre-treatment (screening), or; re-emerges during SOT102 treatment, having been present at the time of pre-treatment (screening), or; worsens in severity during SOT102 treatment relative to the pre-treatment state if the AE is continuous.	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	Causal relationship (relatedness) of all AEs will be assessed by investigators and classified as follows: Not suspected: It is not plausible that the AE is caused by medication/procedure and a likely alternative explanation exists. No reasonable possibility of a causal or temporal relationship.; Suspected: It is plausible that the AE is caused by medication/procedure. Reasonable possibility of a causal relationship.	Day 1 up to approximately 2 years and 8.5 months
Part B (Combination With SoC): Number of Participants With SoC-related AEs	Causal relationship (relatedness) of all AEs will be assessed by investigators and classified as follows: Not suspected: It is not plausible that the AE is caused by medication/procedure and a likely alternative explanation exists. No reasonable possibility of a causal or temporal relationship.; Suspected: It is plausible that the AE is caused by medication/procedure. Reasonable possibility of a causal relationship.	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)	An SAE is any untoward medical occurrence that at any dose fulfills one or more of the following criteria: Results in death; Is immediately life-threatening; Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect; Requires inpatient hospitalization or prolongation of existing hospitalization; Is another medically significant event defined as an event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent any of the above listed outcomes	Day 1 up to approximately 2 years and 8.5 months
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With AEs Leading to Premature Discontinuation of SOT102	AEs (intercurrent illness or trial treatment-related toxicity) that would, in the judgment of the investigator, affect assessments of clinical status to a significant degree or require discontinuation of trial treatment	Day 1 up to approximately 2 years and 8.5 months
Part B (Combination With SoC): Number of Participants With AEs Leading to Premature Discontinuation of SoC	AEs (intercurrent illness or trial treatment-related toxicity) that would, in the judgment of the investigator, affect assessments of clinical status to a significant degree or require discontinuation of trial treatment	Day 1 up to approximately 2 years and 8.5 months
Parts A and B (Monotherapy and Combination With SoC): Number of Participants Who Died	Date of death and immediate and underlying causes of death will be collected.	Day 1 up to approximately 2 years and 8.5 months
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Clinical Laboratory Test Abnormalities (Coagulation, Hematology, Clinical Chemistry and Urinalysis) of Grade 3 or Higher Graded According to NCI CTCAE Version 5.0	The following laboratory parameters will be assessed: Coagulation: prothrombin time, INR; Hematology: leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, differential; Clinical chemistry: ALT, albumin, ALP, amylase, AST, bilirubin, blood urea nitrogen or blood urea, calcium, creatinine, glucose (fasting), LDH, lipase, magnesium, potassium, sodium, TSH (gastric adenocarcinoma only); Urinalysis: blood, glucose, ketones, pH, protein, specific gravity, urine leukocyte esterase	Day 1 up to approximately 2 years and 8.5 months
Parts A and B (Monotherapy and Combination With SoC): Characterization of Cmax of SOT102	Assessment of concentration of SOT102 and its derivates at various timepoints	From Day 1 of Cycle 1 until Day 1 of Cycle 5
Parts A and B (Monotherapy and Combination With SoC): Characterization of Tmax of SOT102	Assessment of concentration of SOT102 and its derivates at various timepoints	From Day 1 of Cycle 1 until Day 1 of Cycle 5
Parts A and B (Monotherapy and Combination With SoC): Characterization of AUClast of SOT102	Assessment of concentration of SOT102 and its derivates at various timepoints	From Day 1 of Cycle 1 until Day 1 of Cycle 5
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Complete Response	Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria	From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Partial Response	Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria	From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Stable Disease	Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria	From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months
Parts A and B (Monotherapy and Combination With SoC): Evidence of SOT102 Activity in Monotherapy in Individual Patients - BOR: Progressive Disease	Detection of anecdotal tumor response in individual patient, as per RECIST 1.1 criteria	From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 2 years and 9 months
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Antibodies Against SOT102	Identification of patients who develop detectable antibodies against any part of SOT102	From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 2 years and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts C and D (monotherapy and combination with SoC): Relationship between the intensity of CLDN18.2 expression and clinical outcome	Correlation between the intensity of CLDN18.2 expression determined by immunohistochemistry staining, and clinical outcome, determined by disease response as per RECIST 1.1 criteria and OS	From Day 1 of Cycle 1 until the end of SOT102 treatment, assessed up to approximately 4 years

Collaborators and Investigators

• Sponsor: SOTIO Biotech a.s.
• Investigators: Principal Investigator: Josep Tabernero, M.D., Ph.D., Vall d'Hebron University Hospital (HUVH)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Advanced Cancer; Metastatic Cancer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Pancreatic Neoplasms
• Other Study ID Numbers: SN201; 2021-005873-25 (EudraCT Number); 2023-504441-31-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No