A clinical study investigating the safety and effect of a potential new therapy mitazalimab in combination with standard chemotherapy treatment in patients with pancreatic cancer

Phase 1

• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma; MedDRA version: 20.0Level: PTClassification code 10073364Term: Ductal adenocarcinoma of pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005182-14-FR
• Lead Sponsor: Alligator Bioscience AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-23
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified