NCT04888312

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Sep 2021

Longer than P75 for phase_1

Geographic Reach
3 countries

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Sep 2021Jun 2026

First Submitted

Initial submission to the registry

May 6, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

May 6, 2021

Last Update Submit

October 6, 2025

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

mitazalimabmodified FOLFIRINOXPancreatic ductal adenocarcinomaPDACPancreatic CancerChemotherapy, combination5-FluorouracilOxaliplatinLeucovorinIrinotecan

Outcome Measures

Primary Outcomes (2)

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

    Number of patients experiencing DLTs

    From 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 study

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

Secondary Outcomes (8)

  • Type, frequency and severity of Adverse Events

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

  • Anti-drug-antibody (ADA) titer in serum (tolerability)

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

  • Cmax of mitazalimab (pharmacokinetics)

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

  • Tmax of mitazalimab (pharmacokinetics)

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

  • AUC(0-T) of mitazalimab (pharmacokinetics)

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

  • +3 more secondary outcomes

Study Arms (1)

Intravenously administered mitazalimab given in combination with chemotherapy

EXPERIMENTAL

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

Interventions

CD40 agonist mitazalimab in combination with chemotherapyBIOLOGICAL

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

Also known as: ADC-1013, JNJ-64457107
Intravenously administered mitazalimab given in combination with chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +9 more criteria

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Cliniques Universitaires St-Luc

Brussels, Belgium

Location

Hospital Erasme

Brussels, Belgium

Location

UZA Antwerp

Edegem, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque,

Bordeaux, France

Location

Centre Lyon Berard

Lyon, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

Hopital Européen Georges Pompidou

Paris, 75015, France

Location

Institute de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Barcelona, Spain

Location

Hospital Universitario La Paz, Madrid, Spain

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal, Madrid, Spain

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio, Sevilla, Spain

Seville, Spain

Location

Hospital Universitario Miguel Servet, Zaragoza, Spain

Zaragoza, Spain

Location

Related Publications (2)

  • 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.

    PMID: 41061701DERIVED

  • 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.

    PMID: 38834087DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapymitazalimab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yago Pico de Coaña, PhD

    Alligator Bioscience AB

    STUDY DIRECTOR

  • Jean-Luc van Laethem, Prof. MD

    Hospital Erasme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 17, 2021

Study Start

September 17, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)BE(4)ES(5)