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Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2OPTIMIZE-1NCT04888312

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

A Phase 1/2 study testing CD40 agonist mitazalimab in combination with chemotherapy in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Alligator Bioscience AB at 14 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
CD40 agonist mitazalimab in combination with chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
14 sitesin 3 countries
Study dates
17 Sep 2021to 30 Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has provided written informed consent
  • Is ≥18 years of age at the time of signing the informed consent form (ICF)
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has a diagnosis of previously untreated metastatic pancreatic ductal adenocarcinoma (histologically documented)
  • Has measurable disease per RECIST v. 1.1
  • Has not received previous chemotherapy for pancreatic ductal adenocarcinoma
Show all 24Show fewer
  • Has not received prior abdominal radiotherapy (except for palliative radiotherapy to non-target lesions)
  • Has a life expectancy of ≥ 3 months
  • Has acceptable hematologic laboratory values defined as:
  • Neutrophils ≥ 1.5 x 109/L without growth factor stimulation within 3 weeks prior to the blood test
  • Platelets ≥100 x 109/L
  • Hemoglobin ≥6.2 mmol/L (~100 g/L) (may be after transfusion)
  • Has acceptable clinical chemistry laboratory values defined as:
  • Bilirubin ≤1.5 x ULN (biliary drainage is permitted)
  • AST ≤3 x ULN (irrespective of hepatic metastases)
  • ALT ≤3 x ULN (irrespective of hepatic metastases)
  • Creatinine ≤1.5 x ULN or glomerular filtration rate (GFR) of ≥45 mL/min
  • INR ≤1.5 x ULN
  • Albumin ≥28 g/L
  • For women of childbearing potential1:
  • Has a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) pregnancy test at screening
  • Is willing to use highly effective contraception methods during study treatment and for at least six months thereafter
  • 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
  • Is willing to comply with all study procedures

Who cannot join

  • Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma
  • 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
  • Has known CNS metastases or carcinomatous meningitis
  • Has contraindication to any constituent of study treatment (mitazalimab and applicable chemotherapy)
  • Has a history of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
  • 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
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  • Has QTc >450 msec
  • Has uncontrolled intercurrent illness, including active infection
  • Has a known history of HIV, hepatitis B or active hepatitis C infection
  • Is a female patient who is pregnant or nursing
  • Has received attenuated vaccine within 28 days before the first dose of study treatment
  • 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
  • Participates in another investigational drug or device study with any intervention within the previous 4 weeks prior to first dose of mitazalimab
  • Has received prior treatment with irinotecan or platinum-containing chemotherapy
  • Has pre-existing peripheral neuropathy greater than grade 1
  • Has known Gilbert's disease
  • Has known genotype UGT1A1 * 28 / * 28
  • Has known fructose intolerance (malabsorption)
  • Has complete dihydropyrimidine dehydrogenase (DPD) deficiency

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

France5 sites

  • Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque,

    Bordeaux

  • Centre Lyon Berard

    Lyon

  • Institut Paoli-Calmettes

    Marseille

  • Hopital Européen Georges Pompidou

    Paris, 75015

  • Institute de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

Other trials in France

Spain5 sites

  • Hospital Universitario Vall d'Hebron, Barcelona, Spain

    Barcelona

  • Hospital Universitario La Paz, Madrid, Spain

    Madrid

  • Hospital Universitario Ramon y Cajal, Madrid, Spain

    Madrid

  • Hospital Universitario Virgen del Rocio, Sevilla, Spain

    Seville

  • Hospital Universitario Miguel Servet, Zaragoza, Spain

    Zaragoza

Other trials in Spain

Belgium4 sites

  • Cliniques Universitaires St-Luc

    Brussels

  • Hospital Erasme

    Brussels

  • UZA Antwerp

    Edegem

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

About this study

Official title: 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

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

Read the detailed description

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.

Being tested
CD40 agonist mitazalimab in combination with chemotherapy
Keywords
mitazalimab, modified FOLFIRINOX, Pancreatic ductal adenocarcinoma, PDAC, Pancreatic Cancer, Chemotherapy, combination, 5-Fluorouracil, Oxaliplatin, Leucovorin, Irinotecan
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD40 agonist mitazalimab in combination with chemotherapyBiological

    Also called ADC-1013, JNJ-64457107

    Mitazalimab administered intravenously every 14 days in combination with standard of care chemotherapy modified FOLFIRINOX.

Study groups in NCT04888312
Study groupRoleWhat they receive
Intravenously administered mitazalimab given in combination with chemotherapyExperimentalMitazalimab, a human monoclonal antibody targeting CD40, administered intravenously every 14 days, in combination with standard of care chemotherapy modified FOLFIRINOX.
Receives: Biological: CD40 agonist mitazalimab in combination with chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities (DLTs) (Part 1: Phase 1b Dose escalation)

    Number of patients experiencing DLTs

    Measured: From first dose to end of dose limiting toxicity period (Day 1-21)

  2. Objective response rate (ORR) (Part 2: Phase 2 Dose expansion)

    Proportion of patients achieving complete response or partial response at any time during the study

    Measured: From first dose to 28-56 days after end of study treatment

Secondary outcomes (8)

  1. Type, frequency and severity of Adverse Events

    Number of patients experiencing AEs. Number of events summarized by SOC and preferred term.

    Measured: From informed consent signed to 28-56 days after end of of study treatment

  2. Anti-drug-antibody (ADA) titer in serum (tolerability)

    Immunogenicity of mitazalimab

    Measured: From first dose until 28-56 days after end of study treatment

  3. Cmax of mitazalimab (pharmacokinetics)

    Cmax derived from mitazalimab serum concentrations

    Measured: From first dose until 28-56 days after end of study treatment

  4. Tmax of mitazalimab (pharmacokinetics)

    Tmax derived from mitazalimab serum concentrations

    Measured: From first dose until 28-56 days after end of study treatment

  5. AUC(0-T) of mitazalimab (pharmacokinetics)

    AUC(0-T) derived from mitazalimab serum concentrations

    Measured: From first dose until 28-56 days after end of study treatment

  6. 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 assessed

    Measured: From first dose until 28-56 days after end of study treatment

  7. Progression free survival (efficacy)

    Number of days from first dose of mitazalimab to progressive disease or death.

    Measured: From first dose and up to 2 years after end of study treatment

  8. Overall survival (efficacy)

    Number of days from first dose of mitazalimab until death

    Measured: From first dose and up to 2 years after end of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start17 Sep 2021
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888312
Sponsor's protocol ID
A-20-1013-C-03
Acronym
OPTIMIZE-1
Status last verified
Oct 2025
First submitted
6 May 2021
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Laethem JL, Geboes K, Borbath I, Macarulla Mercade T, Lambert A, Cassier P, Prenen H, Mitry E, Blanc JF, Pilla L, Feliu J, Rodriguez Garrote M, Pazo-Cid RA, Gallego I, Smith KE, Nordbladh K, Jimenez DG, Ellmark P, Pico de Coana Y, Ambarkhane SV, Beatty GL, O'Reilly EM. CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: Biomarkers associated with outcomes from OPTIMIZE-1. Cell Rep Med. 2025 Oct 21;6(10):102407. doi: 10.1016/j.xcrm.2025.102407. Epub 2025 Oct 7.

    PubMed 41061701

  • 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.

    PubMed 38834087

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD40 agonist mitazalimab in combination with chemotherapy in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Alligator Bioscience AB at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) (Part 1: Phase 1b Dose escalation) (time frame: From first dose to end of dose limiting toxicity period (Day 1-21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888312, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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