mitazalimab for Metastatic pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 1. Has provided written informed consent"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 11. For women of childbearing potential: a. Has a negative highly sensitive serum (β-human chorionic gonadotropin [β-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"}
• {"criterion_text":"- 12. Fertile men must practice effective contraceptive methods (i.e. surgical sterilization, or a condom used with a spermicide) during study treatment and for at least six months thereafter"}
• {"criterion_text":"- 13. Is willing to comply with all study procedures"}
• {"criterion_text":"- 2. Is ≥18 years of age at the time of signing the informed consent form (ICF)"}
• {"criterion_text":"- 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
• {"criterion_text":"- 4. Has a diagnosis of previously untreated metastatic pancreatic ductal adenocarcinoma (histologically documented)"}
• {"criterion_text":"- 5. Has measurable disease per RECIST v. 1.1"}
• {"criterion_text":"- 6. Has not received previous chemotherapy for pancreatic ductal adenocarcinoma"}
• {"criterion_text":"- 7. Has not received prior abdominal radiotherapy (except for palliative radiotherapy to non-target lesions)"}
• {"criterion_text":"- 8. Has a life expectancy of ≥ 3 months"}
• {"criterion_text":"- 9. Has acceptable hematologic laboratory values defined as: a. Neutrophils ≥ 1.5 x 109/L without growth factor stimulation within 3 weeks prior to the blood test b. Platelets ≥100 x 109/L c. Hemoglobin ≥6.2 mmol/L (~100 g/L) (may be after transfusion)"}

Exclusion criteria

• {"criterion_text":"- 1. Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma"}
• {"criterion_text":"- 10. Is a female patient who is pregnant or nursing"}
• {"criterion_text":"- 11. Has received attenuated vaccine within 28 days before the first dose of study treatment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 13. Participates in another investigational drug or device study with any intervention within the previous 4 weeks prior to first dose of mitazalimab"}
• {"criterion_text":"- 14. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has received prior treatment with irinotecan or platinum-containing chemotherapy"}
• {"criterion_text":"- 15. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has pre-existing peripheral neuropathy greater than grade 1"}
• {"criterion_text":"- 16. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known Gilbert's disease"}
• {"criterion_text":"- 17. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known genotype UGT1A1 * 28 / * 28"}
• {"criterion_text":"- 18. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known fructose intolerance (malabsorption)"}
• {"criterion_text":"- 19. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has complete dihydropyrimidine dehydrogenase (DPD) deficiency"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 20. Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment: 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"}
• {"criterion_text":"- 21. Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment: Has a history of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease)"}
• {"criterion_text":"- 22. Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment:\tHas a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)"}
• {"criterion_text":"- 3. Has known CNS metastases or carcinomatous meningitis"}
• {"criterion_text":"- 4. Has contraindication to any constituent of study treatment (mitazalimab and applicable chemotherapy)"}
• {"criterion_text":"- 5. Has a history of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 7. Has QTc >450 msec"}
• {"criterion_text":"- 8. Has uncontrolled intercurrent illness, including active infection"}
• {"criterion_text":"- 9. Has a known history of HIV, hepatitis B or active hepatitis C infection"}

Primary endpoints

• {"endpoint_text":"- Part 1: Incidence of DLTs","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part 2 and Part 3: Objective response rate (ORR).","definition_or_measurement_approach":"Objective response assessed as anti-tumor activity per RECIST v. 1.1 guideline"}

Secondary endpoints

• {"endpoint_text":"- Best Overall Response (BOR), with response categories CR, PR, SD, and PD","definition_or_measurement_approach":"BOR defined using response categories CR, PR, SD, and PD"}
• {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":"Duration measured from response to progression or last follow-up"}
• {"endpoint_text":"- Duration of SD","definition_or_measurement_approach":""}
• {"endpoint_text":"- Disease control rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to next anti-cancer therapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Type, frequency and severity of AEs","definition_or_measurement_approach":"Adverse events categorized by type, frequency and severity (standard safety reporting)"}
• {"endpoint_text":"- Detection and characterization of anti-drug antibody (ADA) titers in serum","definition_or_measurement_approach":"ADA titers detected and characterized in serum samples"}
• {"endpoint_text":"- PK parameters will include Cmax, Tmax, and AUC(0-T). Additional parameters may be calculated depending on data obtained","definition_or_measurement_approach":"Pharmacokinetic parameters to include Cmax, Tmax, AUC(0-T); additional PK parameters as data permit"}
• {"endpoint_text":"- Part 1: Objective response rate (ORR)","definition_or_measurement_approach":"Objective response assessed per RECIST v.1.1"}

Belgium

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

07-10-2024

Processing Time Days

12

Number Of Sites

5

Number Of Participants

40

France

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

17-10-2024

Processing Time Days

2

Number Of Sites

6

Number Of Participants

29

Spain

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

04-10-2024

Processing Time Days

9

Number Of Sites

5

Number Of Participants

25

Primary sponsor

Full Name

Alligator Bioscience AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Theradex (Europe) Limited

Responsibilities

sponsorDuties codes: [1,11,12,2,5,8]; contact: regulatory@theradex.com

Name

Fisher Clinical Services GmbH

Responsibilities

sponsorDuties codes: [14]; contact: reception.basel@thermofisher.com

Name

Charles River Laboratories Edinburgh Limited

Responsibilities

sponsorDuties codes: [4]; contact: EDI-IBB@crl.com

Name

Cerba Research

Responsibilities

sponsorDuties codes: [4]; contact: Info@cerbaresearch.com

Third parties

• {"country":"United Kingdom","full_name":"Charles River Laboratories Edinburgh Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"BC Platforms AB","duties_or_roles":"sponsorDuties codes: [10,6]","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Theradex (Europe) Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,2,5,8]","organisation_type":"Pharmaceutical company"}
• {"country":"Sweden","full_name":"ClinStorage AB","duties_or_roles":"sponsorDuties codes: [15]; value: Storage of biological samples","organisation_type":"Pharmaceutical company"}