Pancreatic CancerPhase 1/2CLAUDIO-01NCT05525286
Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma
A Phase 1/2 study testing SOT102 in people with Pancreatic Cancer, run by SOTIO Biotech a.s. at 8 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SOT102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 31 Mar 2022to 13 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States2 sites
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Belgium2 sites
Institut Jules Bordet
Brussels
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Spain2 sites
VHIO - Vall d'Hebron Institut d'Oncologia
Barcelona
Hospital Universitario HM Sanchinarro
Madrid
About this study
Official title: 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.
Read the 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
- Being tested
- SOT102
- Keywords
- Pancreatic Cancer, Advanced Cancer, Metastatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOT102Drug
SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: SOT102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start31 Mar 2022
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Why it stopped: Trial terminated by Sponsor based on benefit- risk reassessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- SN201 is a multi-modular clinical trial in patients with pancreatic adenocarcinoma.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO Biotech a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Tabernero, M.D., Ph.D., Principal investigator, Vall d'Hebron University Hospital (HUVH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525286
- Sponsor's protocol ID
- SN201
- Other IDs
- 2021-005873-25, 2023-504441-31-00, 2023
- Acronym
- CLAUDIO-01
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2021
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05525286
- Acronym / sponsor ID
- CLAUDIO-01 / SN201
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Advanced Cancer, Metastatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated by Sponsor based on benefit- risk reassessment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SOTIO Biotech a.s.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- SN201 is a multi-modular clinical trial in patients with pancreatic adenocarcinoma.
| Arm | Type | Receives |
|---|---|---|
| SOT102 as Monotherapy (Part A) DL1 0.032 mg/kg | Experimental | Drug: SOT102Patients 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. |
| SOT102 as Monotherapy (Part A) DL2 0.064 mg/kg | Experimental | Drug: SOT102Patients 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. |
| SOT102 as Monotherapy (Part A) DL3 0.128 mg/kg | Experimental | Drug: SOT102Patients 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. |
| SOT102 as Monotherapy (Part A) DL4 0.214 mg/kg | Experimental | Drug: SOT102Patients 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. |
| SOT102 in Combination With SoC (Part B) DL1 0.032 mg/kg | Experimental | Drug: SOT102Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOT102SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety. | Drug | 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 |
Primary outcome
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
Time frame: Through Cycles 1-2 (28 days)
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.
Parts C and D: The Assessment of the Efficacy of SOT102 in Monotherapy and in Combination With First-line SoC Treatment
Time frame: 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
Efficacy is determined by objective response rate (ORR) determined according to RECIST 1.1 criteria
17 secondary outcomes
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With DLTs
Time frame: Through Cycles 1-2 (28 days)
Parts A and B (Monotherapy and Combination With SoC): Number of Participants With Treatment-emergent AEs (TEAEs)
Time frame: 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
Time frame: Day 1 up to approximately 2 years and 8.5 months
Part B (Combination With SoC): Number of Participants With SoC-related AEs
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Tabernero, M.D., Ph.D. principal investigator
Vall d'Hebron University Hospital (HUVH)
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SOT102 in people with Pancreatic Cancer, run by SOTIO Biotech a.s. at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Spain, Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Through Cycles 1-2 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.