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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005873-25 | EudraCT Number | ||
| 2023-504441-31-00 | EU Trial (CTIS) Number |
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Trial terminated by Sponsor based on benefit- risk reassessment
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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.
The trial will have the following parts:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOT102 | Drug | SOT102 is an antibody-drug conjugate (ADC) targeting CLDN18.2 with the anthracycline PNU as cytotoxic moiety. |
|
| 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 |
| 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 |
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Inclusion Criteria:
All Parts (key criteria)
Part A
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)
Part B/D (key)
*Patients with contraindications to any component of the first-line SoC treatment
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| Name | Affiliation | Role |
|---|---|---|
| Josep Tabernero, M.D., Ph.D. | Vall d'Hebron University Hospital (HUVH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States | ||
| Cleveland Clinic Main Campus |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Level 1: 0.032 mg/kg |
| |||||||||||||
| Dose Level 2: 0.064 mg/kg |
| |||||||||||||
| Dose Level 3: 0.128 mg/kg |
| |||||||||||||
| Dose Level 4: 0.214 mg/kg |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | SOT102 as Monotherapy (Part A) DL2 0.046 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | DLT evaluable patients were those who have received 2 doses of SOT102 per schedule (day 1 of cycle 1 and day 1 of cycle 2) with the maximum postponement of cycle 2 by 1 day (as agreed by the sponsor) and completed the evaluation period of 28 days. Also patients who experienced a treatment emergent adverse event at any time during the DLT evaluation period that met the definition of a DLT. | Posted | Count of Participants | Participants | Through Cycles 1-2 (28 days) |
Day 1 up to approximately 2 years and 8.5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Kapsa | SOTIO Biotech a.s. | (+420) 2241 74448 | kapsa@sotio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2024 | Jul 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2025 | Sep 23, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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SN201 is a multi-modular clinical trial in patients with pancreatic adenocarcinoma.
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|
| 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:
| 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:
| 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:
| 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:
| 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:
| 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 |
| Cleveland |
| Ohio |
| 44195 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | SOT102 in Combination With SoC (Part B) 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. 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. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG status | As per the Inclusion criteria, only patients with ECOG performance status ≤1 (i.e., ECOG performance status 0 or 1) could participate in the trial. This measure shows distribution of the status across safety population. As per the ECOG status scale, 0 means patients who are fully active, able to carry on all pre-disease performance without restriction. 1 means patients, who are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. | Count of Participants | Participants |
|
| Weight at baseline | Mean | Standard Deviation | kilograms |
|
| Height at baseline | Mean | Standard Deviation | meters |
|
| BSA at baseline | Mean | Standard Deviation | square meters |
|
| ID | Title | Description |
|---|
| OG000 | SOT102 as Monotherapy (Part A) | Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses of SOT102 given once every 14 days via the IV route over 45 (±15) minutes. |
| OG001 | SOT102 in Combination With SoC (Part B) | Patients with CLDN18.2-positive pancreatic adenocarcinoma were treated with escalating doses 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. |
|
|
| Primary | 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 | Part C and Part D were not initiated, no population was analyzed. | Posted | 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 | 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 | Patients who received 2 doses of SOT102 per schedule (day 1 of cycle 1 and day 1 of cycle 2). Patients must have completed evaluation period of 28 days. Pancreatic patients must have received three doses of SoC (days 1, 8, and 15 of cycle 1), gastric patients must have received 2 doses of SoC per schedule (day 1 of cycle 1 and day 1 of cycle 2). Patients who experienced an adverse event at any time during the DLT evaluation period that met the definition of a DLT were included. | Posted | Count of Participants | Participants | Through Cycles 1-2 (28 days) |
|
|
|
| Secondary | 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:
| Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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:
| Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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:
| Patients exposed to at least one dose of SoC | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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:
| Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SoC | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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. | Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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:
| Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | Day 1 up to approximately 2 years and 8.5 months |
|
|
|
| Secondary | 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 | Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients. | Posted | Median | Full Range | ng/mL | From Day 1 of Cycle 1 until Day 1 of Cycle 5 |
|
|
|
| Secondary | 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 | Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients. | Posted | Median | Full Range | hours | From Day 1 of Cycle 1 until Day 1 of Cycle 5 |
|
|
|
| Secondary | 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 | Patients who had at least 1 post-dose concentration measurement above the lower limit of quantification. No data was collected for Part B due to the low number of patients. | Posted | Median | Full Range | h*ng/mL | From Day 1 of Cycle 1 until Day 1 of Cycle 5 |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 who had at least one evaluable tumor assessment per RECIST v1.1 after the initiation of SOT102 treatment | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | 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 | Patients exposed to at least one dose of SOT102 | Posted | Count of Participants | Participants | 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 |
|
|
|
| 2 |
| 4 |
| 4 |
| 4 |
| 4 |
| 4 |
| EG001 | 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. | 5 | 11 | 5 | 11 | 9 | 11 |
| EG002 | 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. | 3 | 9 | 5 | 9 | 8 | 9 |
| EG003 | 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. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG004 | 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. | 0 | 4 | 0 | 4 | 4 | 4 |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Protoeinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Nephroangiosclerosis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| Neutrophil count decreased | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Platelet count decreased | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Blood bilirubin increased | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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The results will be published and/or presented at scientific meetings in their totality in a timely manner. Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns.
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |