First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

Summary

This study is investigating a new experimental therapy, MP0317, a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40. Preclinical studies suggest that MP0317 may provide benefit for the treatment of tumors known to express high levels of FAP and for which approved therapies have been exhausted. This is the first study of MP0317 in humans and its main purpose is to test its safety and tolerability in patients with advanced solid tumors. This study will also examine the blood levels of MP0317 at several increasing dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity.

Timeline

Start

2021-10-11

Primary completion

2024-01-19

Completion

2024-01-19

Publications

• Steeghs N, Gomez-Roca C, Korakis I, Gort E, De Winter H, Stojcheva N, Stavropoulou V, Krieg J, Baverel P, Fernandez E, Florescu AM, Hoenig L, Sanderson MP, Kirkin V, Legenne P, Cassier PA. Tumor-localized CD40 agonism with MP0317, a FAP x CD40 DARPin, reprograms the tumor microenvironment in patients with advanced solid tumors: an open-label, nonrandomized, dose-escalation phase 1 study. Nat Cancer. 2026 May;7(5):810-822. doi: 10.1038/s43018-026-01150-1. Epub 2026 May 1.
• Rigamonti N, Veitonmaki N, Domke C, Barsin S, Jetzer S, Abdelmotaleb O, Bessey R, Lekishvili T, Malvezzi F, Gachechiladze M, Behe M, Levitsky V, Trail PA. A Multispecific Anti-CD40 DARPin Construct Induces Tumor-Selective CD40 Activation and Tumor Regression. Cancer Immunol Res. 2022 May 3;10(5):626-640. doi: 10.1158/2326-6066.CIR-21-0553.

Drugs

Indications