Authorised Phase I and Phase II (Integrated)- Other Metastatic pancreatic ductal adenocarcinoma

An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

EU CTIS ID: 2024-514905-79-00

What this study is testing

Part 1: To determine the recommended Phase 2 dose (RP2D) of mitazalimab in combination with chemotherapy Part 2 and 3: To assess the clinical activity of mitazalimab in combination with chemotherapy (i.e., anti-tumor activity as per RECIST v. 1.1 guideline)

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Has provided written informed consent
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 (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
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
13. Is willing to comply with all study procedures
2. Is ≥18 years of age at the time of signing the informed consent form (ICF)

You likely can't join if

1. Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma
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
13. Participates in another investigational drug or device study with any intervention within the previous 4 weeks prior to first dose of mitazalimab
14. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has received prior treatment with irinotecan or platinum-containing chemotherapy

See the full eligibility criteria

Who can join

1. Has provided written informed consent
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 (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
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
13. Is willing to comply with all study procedures
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 lesions)
8. Has a life expectancy of ≥ 3 months
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)

What rules you out

1. Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma
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
13. Participates in another investigational drug or device study with any intervention within the previous 4 weeks prior to first dose of mitazalimab
14. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has received prior treatment with irinotecan or platinum-containing chemotherapy
15. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has pre-existing peripheral neuropathy greater than grade 1
16. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known Gilbert's disease
17. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known genotype UGT1A1 * 28 / * 28
18. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has known fructose intolerance (malabsorption)
19. Additional exclusion criteria only applicable for mFOLFIRINOX treatment: Has complete dihydropyrimidine dehydrogenase (DPD) deficiency
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
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
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)
22. Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment: Has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
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
8. Has uncontrolled intercurrent illness, including active infection
9. Has a known history of HIV, hepatitis B or active hepatitis C infection

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.