drugset / Trial / NCT04888312
Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Pancreatic Cancer Patients
NaSingle-groupOpen-labelTreatment
Summary
Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.
Timeline
- Start
- 2021-09-17
- Primary completion
- 2026-06-01
- Completion
- 2026-06-30
Outcome
Met primary endpoint
paper The primary endpoint (objective response rate >30%) was met (objective response rates in 23 [40%]; one-sided 90% CI ≥32 of 57 patients). PMID 38834087 ↗
release “OPTIMIZE-1 achieved its primary endpoint” alligatorbioscience.se ↗
release “The OPTIMIZE-1 study met its primary endpoint, with a confirmed objective response rate of 42.1% in the Phase 2 cohort.” alligatorbioscience.se ↗
release “top line data was announced on 29 January 2024 showing that the trial met the primary endpoint.” alligatorbioscience.se ↗
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitazalimab | Monoclonal antibody | 450 ug/kg | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 900 ug/kg | Intravenous |