NCT05159388

A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

A First in Human Phase 1-2 Open-Label, Multicenter, Dose Escalation and Expansion Study of PRS-344/S095012 in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Servier Bio-Innovation LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors.

Detailed description

The trial is an open-label, multi-center safety trial of PRS-344/S095012. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	PRS-344/S095012	PRS-344/S095012 Monotherapy

Timeline

• Start date: 2021-09-08
• Primary completion: 2025-04-08
• Completion: 2025-04-08
• First posted: 2021-12-16
• Last updated: 2025-07-08

Locations

11 sites across 4 countries: United States, Australia, Belgium, Spain

Regulatory

• FDA-regulated drug study