Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Active not recruiting

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

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

NCT04888312↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Ongoing
Phase
Phase 1 / Phase 2
Status
Active not recruiting
Study type
Interventional
Start
17 September 2021
Expected end
30 June 2026
Enrollment
94 participants
Sites
14
Primary outcomes
Incidence of Dose Limiting Toxicities (DLTs) (Part 1: Phase 1b Dose escalation); Objective response rate (ORR) (Part 2: Phase 2 Dose expansion)
Sponsor
Industry
Results posted
No
Last update
8 October 2025

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

Brief summary public domain (ClinicalTrials.gov)

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

Detailed description public domain (ClinicalTrials.gov)

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.

Papers 2