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Neoplasms, Glandular and Epithelial

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Folfirinox

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

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

CD40 agonist mitazalimab in combination with chemotherapy

Philip Van Der Veen

Karin Nordbladh

Trong Le

Amélie Planchon

Ivan Borbath, Prof. MD

Axelle Ghilain

Camilla Previtali

Jean-Luc van Laethem, Prof. MD

Amélie Lyssens

Julia Lenaerts

Hans Prenen, Prof. MD

Tine Derre

Roxane Vanvynckt

Karen Geboes, Prof. MD

Amandine Mourthé, Coordinator

Camille Ducerf, Coordinator

Jean-Frederic Blanc

Marielle Bosse-Platiere

Caroline Fezelot

Philippe Cassier, MD, PhD

Azauz Hanene, Coordinator

Emmanuel Jean Mitry, Prof.

Xavier Bulsei

Chérifa Kadouci

Aurélian Lambert, MD, PhD

Jordi Perera Rabaiget

Marta Horcas

Teresa Macarulla Mercadé, MD

Melina Martin, Coordinator

Pilar Boyero

Jaime Feliu-Batlle, MD

Cristina Carrera, Coordinator

Isabel Farhanem

Mercedes Rodriguez-Garrote, MD

Laura Bernal Iriarte, Coordinator

Esperanza Muñoz

Inmaculada Gallego Jiménez, MD

Sergi Recasens, Coordinator

Roberto Antonio Pazo-Cid, MD

Sumeet Ambarkhane, MD

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.

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

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

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

Cmax derived from mitazalimab serum concentrations

Tmax derived from mitazalimab serum concentrations

AUC(0-T) derived from mitazalimab serum concentrations

Best overall response, duration of response, Duration of stable disease, disease control rate, Time to next anti-cancer therapy will be assessed

Spots Global Cancer Trial Database for cd40 agonist mitazalimab in combination with chemotherapy