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MP0317

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

Ensayo de MOLECULAR PARTNERS AG en Advanced Malignant Solid Tumor (del registro, en inglés).

Fase

Fase 1

Estado

Interrumpido

Participantes

46

previstos

Centros

4

Fin del objetivo primario

ene 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en oct 2021.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «After completion of the dose-escalation part of the study, the safety profile of MP0317 in monotherapy is considered adequately characterized in the dose-escalation part of the study.».

Qué mide

Type, incidence and severity of AEs and serious adverse events (SAEs) (From first study drug administration and until 28 days after the last study drug administration or end of study (EOS)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de MOLN

Todos los de MOLN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05098405), actualizada en ene 2025.