Metastatic Pancreatic Ductal Adenocarcinoma MedDRA version: 20.0 Level: PT Classification code 10073364 Term: Ductal adenocarcinoma of pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: mitazalimab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: mitazalimab
Other descriptive name: ADC-1013, JNJ-64457107
Concentration unit: mg
Sponsors
Alligator Bioscience AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Has provided written informed consent 2.Is =18 years of age at the time of signing the informed consent form (ICF) 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Has a diagnosis of previously untreated metastatic pancreatic ductal adenocarcinoma (histologically documented) 5. Has measurable disease per RECIST v. 1.1 6. Has not received previous chemotherapy for pancreatic ductal adenocarcinoma 7. Has not received prior abdominal radiotherapy (except for palliative radiotherapy to non-target l lesions) 8. Has a life expectancy of = 3 months 9. Has acceptable hematologic laboratory values defined as: a. Neutrophils = 1.5 x 10^9/L without growth factor stimulation within 3 weeks prior to the blood test b. Platelets =100 x 10^9/L c. Hemoglobin =5.9 mmol/L (~95 g/L) (may be after transfusion) 10. Has acceptable clinical chemistry laboratory values defined as: a. Bilirubin =1.5 x ULN (biliary drainage is permitted) b. AST =3 x ULN (irrespective of hepatic metastases) c. ALT =3 x ULN (irrespective of hepatic metastases) d. Creatinine =1.5 x ULN or glomerular filtration rate (GFR) of =45 mL/min (see APPENDIX 4 for calculation of GFR) e. INR =1.5 x ULN f. Albumin =28 g/L 11. For women of childbearing potential: a. Has a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) pregnancy test at screening b. Is willing to use highly effective contraception methods (defined in APPENDIX 5) during study treatment and for at least six months thereafter 12. Is willing to comply with all study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma 2. Has other current cancer or history of cancer in the prior 3 years before signing the ICF other than in situ cervical cancer, or basal cell or squamous cell carcinoma treated with local excision only 3. Has known CNS metastases or carcinomatous meningitis 4. Has contraindication to any constituent of study treatment (mitazalimab and applicable chemotherapy) 5. Has a history of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction 6. Has a history of myocardial infarction within 12 months of the first administration of mitazalimab, uncontrolled angina pectoris, unstable cardiac arrhythmias, or congestive heart failure of New York Heart Association class II or greater 7. Has QTc >450 msec if male and QTc >470 msec if female 8. Has uncontrolled intercurrent illness, including active infection 9. Has a known history of HIV, hepatitis B or active hepatitis C infection 10. Is a female patient who is pregnant or nursing 11. Has received attenuated vaccine within 28 days before the first dose of study treatment 12. Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient’s compliance with the study Additional exclusion criteria only applicable for mFOLFIRINOX treatment: 13. Has received prior treatment with irinotecan or platinum-containing chemotherapy 14. Has pre-existing peripheral neuropathy greater than grade 1 15. Has known Gilbert's disease 16. Has known genotype UGT1A1 * 28 / * 28 17. Has known fructose intolerance (malabsorption) 18. Has complete dihydropyrimidine dehydrogenase (DPD) deficiency Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment: 13. Has a history of slowly progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity, pneumonitis or multiple allergies 14. Has a history of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease) 15. Has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 (Phase 1b): To determine the recommended Phase 2 dose (RP2D) of mitazalimab in combination with chemotherapy Part 2 (Phase 2): To assess the clinical activity of mitazalimab in combination with chemotherapy (i.e., anti-tumor activity as per RECIST v. 1.1 guideline);Secondary Objective: Part 1 (Phase 1b): To assess the safety and tolerability of mitazalimab in combination with chemotherapy. To assess the immunogenicity of mitazalimab. To assess pharmacokinetics (PK) of mitazalimab after single and repeated administrations. To assess the clinical activity of mitazalimab in combination with chemotherapy (i.e., anti-tumor activity as per RECIST v. 1.1 guideline). To assess survival outcomes following repeated administrations of mitazalimab in combination with chemotherapy. Part 2 (Phase 2): To assess the clinical activity of mitazalimab in combination with chemotherapy (i.e., anti-tumor activity as per RECIST v. 1.1 guideline). To assess survival outcomes following repeated administrations of mitazalimab in combination with chemotherapy. To assess the safety and tolerability of mitazalimab in combination with chemotherapy. To assess the immunogenicity of mitazalimab. To assess pharmacokinetics (PK) of mitazalimab after single and repeated administrations. ;Primary end point(s): Part 1 (Phase 1b): Incidence of DLTs Part 2 (Phase 2): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: Part 1 (Phase 1b): Mitazalimab in combination with mFOLFIRINOX: The time from the first dose of mitazalimab (Day 1) until Day 21 in the first treatment cycle (Cycle 1). Mitazalimab in combination with gemcitabine plus nab-paclitaxel: The time from the first dose of mitazalimab (Day 1) until Day 28 within the first treatment cycle of 35 days (Cycle 1). Part 2 (Phase 2): Duration of part 2 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1 (Phase 1b): •Type, frequency and severity of adverse events (AEs) •Detection and characterization of anti-drug antibody (ADA) titers in serum •PK parameters will include Cmax, Tmax, and AUC(0-T). Additional parameters may be calculated depending on data obtained •Objective response rate (ORR) •Best Overall Response (BOR), with response categories CR, PR, SD, and PD •Duration of response (DoR) •Duration of SD •Disease control rate •Time to next anti-cancer therapy •Progression-free survival (PFS) •Overall survival (OS) Part 2 (Phase 2): •Best Overall Response (BOR), with response categories CR, PR, SD, and PD •Duration of response (DoR) •Duration of SD •Disease control rate •Time to next anti-cancer therapy •Progression-free survival (PFS) •Overall survival (OS) •Type, frequency and severity of AEs •Detection and characterization of anti-drug antibody (ADA) titers in serum •PK parameters will include Cmax, Tmax, and AUC(0-T). Additional parameters may be calculated depending on data obtained ;Timepoint(s) of evaluation of this end point: Duration of the study | — |
Countries
France
Contacts
Public ContactRegulatory Affairs
Theradex (Europe) Ltd
Outcome results
None listed