WHO ICTRP trial

A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with…

EUCTR2019-003456-36-BE · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2019-003456-36-BE
Public title A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumors
Scientific title A first in human Phase 1/2 open-label, multicenter, dose escalation and expansion study of PRS-344/S095012 in patients with solid tumors
Primary sponsor Institut de Recherches Internationales Servier
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Belgium;United States;Brazil;Australia;France;Switzerland;Spain
Conditions Advanced and/or metastatic solid tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: S095012 Product Code: S095012 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: S095012 Other descriptive name: PRS-344 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal…
Registration date Oct 6, 2021
Target size 277
Secondary IDs CL1-95012-001
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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