Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

November 23, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

May 31, 2026

Conditions
Advanced Soft-tissue SarcomaAdvanced L-sarcomasOther Advanced SarcomasAdvanced Solid TumorLocalized Soft-tissue Sarcoma
Interventions
DRUG

PM14

"Pharmaceutical form: PM14 drug product is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 5.0 mg of the active moiety.~Route of administration: PM14 drug product was developed for administration by the i.v. route. Before use, the vials are reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion to give a solution containing 0.5 mg/mL of PM14. Prior to administration, the reconstituted DP solution should be further diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion. Each vial of PM14 5.0 mg is a single use vial."

Trial Locations (4)

28040

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

50009

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08041

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

All Listed Sponsors
lead

Grupo Espanol de Investigacion en Sarcomas

OTHER