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2022-03-31
2024-12-13
2024-12-13
44
NCT05525286
Sotio Biotech Inc.
Sotio Biotech Inc.
INTERVENTIONAL
Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced 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.
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)
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-12-07 | N/A | 2025-01-10 |
2022-08-30 | N/A | 2025-01-13 |
2022-09-01 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: SOT102 SOT102 is administered as intravenous infusion over 45 minutes as monotherapy or in combination with established standard of care therapy, every 14 days until the disease progression or intolerance to SOT102. SoC therapy is administered as per approved lo | DRUG: SOT102
|
| Primary Outcome Measures | 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. | 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, assessed up to approximately 4 years |
| Secondary Outcome Measures | 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 amylas | 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. | From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| 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. | From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| 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 | From the date of the patient's signing the Informed Consent Form (ICF) until 30 (+5) days after the last dose of SOT102, assessed up to approx. 4 years; SAEs with a suspected causal relationship to SOT102 per the investigator's judgment: at any |
| 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 | From Day 1 of Cycle 1 until the end of SOT102 treatment, assessed up to approximately 4 years |
| 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. | From the date of the patient's signing the ICF until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 4 years |
| 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 | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts A and B (monotherapy and combination with SoC): Characterization of pharmacokinetics (PK) of total SOT102 and its derivates | 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 | 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 4 years |
| 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 4 years |
| Parts C and D (monotherapy and combination with SoC): Duration of response (DoR) according to RECIST 1.1 | The DoR is defined as the time from the first achieved response (complete or partial, confirmed) until the first date of radiological progression or death. | From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Progression-free survival (PFS) according to RECIST 1.1 | PFS is defined as the time from trial enrolment until the first date of radiological progression or death. | From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 4 years |
| Part C (monotherapy): Clinical benefit rate (CBR) according to RECIST 1.1 | The CBR is defined as the number of complete responses, partial responses, and stable diseases from all evaluable best overall responses. | From Day 1 of Cycle 1 until disease progression or start of new anticancer therapy, whichever is first, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Overall survival (OS) | OS is defined as the time from eligibility verification until the date of death. | From Day 1 of Cycle 1 until the end of the trial, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Number of participants with 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. | From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (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. | From Day 1 of Cycle 1 until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Number of participants with 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 | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years; SAEs with a suspected causal relationship to SOT102 per the investigator's judgment: at any time |
| Parts C and D (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 | From Day 1 of Cycle 1 until the end of SOT102 treatment, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Number of participants who died | Date of death and immediate and underlying causes of death will be collected. | From the date of the patient's signing the ICF until the end of the trial, assessed up to approximately 4 years |
| Parts C and D (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 | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC, patients with gastric cancer): Patient-reported quality of life questionnaire EORTC QLQ-C30 scores | To determine the effect of trial intervention on the quality of life. | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC, patients with gastric cancer): Patient-reported quality of life questionnaire EORTC QLQ-STO22 scores | To determine the effect of trial intervention on the quality of life. | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC, patients with pancreatic cancer): Patient-reported quality of life questionnaire EORTC QLQ-C30 scores | To determine the effect of trial intervention on the quality of life. | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC, patients with pancreatic cancer): Patient-reported quality of life questionnaire EORTC QLQ-PAN26 scores | To determine the effect of trial intervention on the quality of life. | From the date of the patient's signing the ICF until 30 (+5) days after the last dose of SOT102, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Patient-reported quality of life questionnaire EQ-5D-3L scores | To determine the effect of trial intervention on the quality of life. | From the date of the patient's signing the ICF until the end of the trial, assessed up to approximately 4 years |
| Parts C and D (monotherapy and combination with SoC): Characterization of PK of total SOT102 and its derivates | Assessment of concentration of SOT102 and its derivates at various timepoints | From Day 1 of Cycle 1 until the end of SOT102 treatment, assessed up to approximately 4 years |
| Parts C and D (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 the end of SOT102 treatment, assessed up to approximately 4 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
