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Clinical Trial Record

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Safety and Efficacy of Mitazalimab in Combination with Chemotherapy in Pancreatic Cancer Patients

2021-09-17

2024-01-29

2026-06-30

94

Study Overview

Safety and Efficacy of Mitazalimab in Combination with Chemotherapy in Pancreatic Cancer Patients

Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

OPTIMIZE-1 is a phase 1b/2, open-label, multi-center study assessing the clinical efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. The efficacy of intravenously administered mitazalimab in combination with the standard of care chemotherapy mFOLFIRINOX will be evaluated in patients with metastatic pancreatic ductal adenocarcinoma. Two dose levels of mitazalimab, 450 ug/kg and 900 ug/kg, are planned to be evaluated together with mFOLFIRINOX for determination of recommended phase 2 dose (RP2D) of mitazalimab in combination with mFOLFIRINOX before entering a dose expansion part with RP2D obtained. The expansion part will evaluate the clinical efficacy of mitazalimab in combination with mFOLFIRINOX assessing objective response rate (ORR), primary endpoint, as well as Progression-free survival (PFS) and Overall survival (OS). The dose expansion part includes a Simon´s two-stage design with an interim analysis for stop for futility or efficacy based on ORR.

  • Metastatic Pancreatic Ductal Adenocarcinoma
  • BIOLOGICAL: CD40 agonist mitazalimab in combination with chemotherapy
  • A-20-1013-C-03

Study Record Dates

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

2021-05-06  

N/A  

2025-01-10  

2021-05-11  

N/A  

2025-01-13  

2021-05-17  

N/A  

2025-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Intravenously administered mitazalimab given in combination with chemotherapy

Mitazalimab, a human monoclonal antibody targeting CD40, administered intravenously every 14 days, in combination with standard of care chemotherapy modified FOLFIRINOX.

BIOLOGICAL: CD40 agonist mitazalimab in combination with chemotherapy

  • Mitazalimab administered intravenously every 14 days in combination with standard of care chemotherapy modified FOLFIRINOX.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of Dose Limiting Toxicities (DLTs) (Part 1: Phase 1b Dose escalation)Number of patients experiencing DLTsFrom first dose to end of dose limiting toxicity period (Day 1-21)
Objective response rate (ORR) (Part 2: Phase 2 Dose expansion)Proportion of patients achieving complete response or partial response at any time during the studyFrom first dose to 28-56 days after end of study treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Type, frequency and severity of Adverse EventsNumber of patients experiencing AEs. Number of events summarized by SOC and preferred term.From informed consent signed to 28-56 days after end of of study treatment
Anti-drug-antibody (ADA) titer in serum (tolerability)Immunogenicity of mitazalimabFrom first dose until 28-56 days after end of study treatment
Cmax of mitazalimab (pharmacokinetics)Cmax derived from mitazalimab serum concentrationsFrom first dose until 28-56 days after end of study treatment
Tmax of mitazalimab (pharmacokinetics)Tmax derived from mitazalimab serum concentrationsFrom first dose until 28-56 days after end of study treatment
AUC(0-T) of mitazalimab (pharmacokinetics)AUC(0-T) derived from mitazalimab serum concentrationsFrom first dose until 28-56 days after end of study treatment
Anti-tumor Activity per RECIST 1.1 guideline (efficacy)Best overall response, duration of response, Duration of stable disease, disease control rate, Time to next anti-cancer therapy will be assessedFrom first dose until 28-56 days after end of study treatment
Progression free survival (efficacy)Number of days from first dose of mitazalimab to progressive disease or death.From first dose and up to 2 years after end of study treatment
Overall survival (efficacy)Number of days from first dose of mitazalimab until deathFrom first dose and up to 2 years after end of study treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

    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 lesions) 8. Has a life expectancy of ≥ 3 months 9. Has acceptable hematologic laboratory values defined as:
    1. Neutrophils ≥ 1.5 x 109/L without growth factor stimulation within 3 weeks prior to the blood test 2. Platelets ≥100 x 109/L 3. Hemoglobin ≥6.2 mmol/L (~100 g/L) (may be after transfusion) 10. Has acceptable clinical chemistry laboratory values defined as:
    1. Bilirubin ≤1.5 x ULN (biliary drainage is permitted) 2. AST ≤3 x ULN (irrespective of hepatic metastases) 3. ALT ≤3 x ULN (irrespective of hepatic metastases) 4. Creatinine ≤1.5 x ULN or glomerular filtration rate (GFR) of ≥45 mL/min 5. INR ≤1.5 x ULN 6. Albumin ≥28 g/L 11. For women of childbearing potential1:
    1. Has a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) pregnancy test at screening 2. Is willing to use highly effective contraception methods 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
    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 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 13. Participates in another investigational drug or device study with any intervention within the previous 4 weeks prior to first dose of mitazalimab 14. Has received prior treatment with irinotecan or platinum-containing chemotherapy 15. Has pre-existing peripheral neuropathy greater than grade 1 16. Has known Gilbert's disease 17. Has known genotype UGT1A1
  • 28 /
  • 28 18. Has known fructose intolerance (malabsorption) 19. Has complete dihydropyrimidine dehydrogenase (DPD) deficiency

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Theradex
  • BC Platforms
  • STUDY_DIRECTOR: Sumeet Ambarkhane, MD, Alligator Bioscience AB

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Van Laethem JL, Borbath I, Prenen H, Geboes KP, Lambert A, Mitry E, Cassier PA, Blanc JF, Pilla L, Batlle JF, Garrote MR, Pazo-Cid RA, Gallego I, Smith KE, Ellmark P, Pico de Coana Y, Ambarkhane SV, Macarulla T. Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study. Lancet Oncol. 2024 Jul;25(7):853-864. doi: 10.1016/S1470-2045(24)00263-8. Epub 2024 Jun 1.
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