Clinical Trials Logo

Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04888312
Study type Interventional
Source Alligator Bioscience AB
Contact Philip Van Der Veen
Phone +44(0) 1293 510319
Email PVanDerVeen@Theradex.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 17, 2021
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04935359 - Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2 Phase 3
Active, not recruiting NCT05095064 - Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan
Active, not recruiting NCT05039177 - A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies Phase 1/Phase 2
Terminated NCT04390763 - Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Phase 2
Not yet recruiting NCT06206876 - FL118 for Treating Patients With Advanced Pancreatic Ductal Adenocarcinoma Phase 1
Recruiting NCT05642962 - Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC) Phase 1/Phase 2
Completed NCT02501902 - Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC Phase 1
Active, not recruiting NCT04581343 - A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic PC Patients Phase 1
Completed NCT02558894 - Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma Phase 2
Terminated NCT02732938 - Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients Phase 2
Recruiting NCT05472259 - A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC) Phase 2
Recruiting NCT06445062 - Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors Phase 1/Phase 2
Recruiting NCT02600949 - Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer Phase 1
Recruiting NCT05630183 - A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer Phase 2
Completed NCT02583477 - Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma Phase 1/Phase 2
Terminated NCT04329949 - Study of Relacorilant in Combination With Nab-Paclitaxel in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Phase 3
Terminated NCT02101021 - Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Phase 3
Suspended NCT05685602 - CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer Phase 1
Not yet recruiting NCT06398587 - Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma Phase 2
Completed NCT04990037 - A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma Phase 1