Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

August 28, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Dacarbazine

Dacarbazine (DTIC), 1000 mg/m2 or 850 mg/m2 on Day 1 of every 21-day cycle (based on results and DSMB evaluation in the safety run-in part of the study)

DRUG

onfekafusp alfa

L19TNF, 13 μg/kg, on Day 1, 3, and 5 of every 21-day cycle for a maximum of 6 induction cycles. Patients experiencing apparent or real benefit with minimal or acceptable toxicity from the first 6 cycles of treatment, can receive, at investigator's discretion, maintenance treatment of 13 μg/kg, on Day 1 every 21-day

Trial Locations (23)

10043

AOU San Luigi Gonzaga, Orbassano

13009

Institut Paoli-Calmettes, Marseille

25000

Hopital Jean Minjoz, Besançon

31059

Institut Claudius Regaud, Toulouse

34298

Institut régional du Cancer de Montepellier - ICM Val d'Aurelle, Montpellier

48149

Münster University Hospital, Münster

63011

Centre Jean Perrin, Clermont-Ferrand

Unknown

Institut Bergonié, Bordeaux

Centre Léon Bérard, Lyon

Institut Gustave Roussy, Villejuif

Helios Klinikum Bad Saarow, Bad Saarow

Helios Klinikum Berlin- Buch, Berlin

Klinik rechts der Isar, TU München, München

IRCCS - Istituto Ortopedico Rizzoli, Bologna

IRCCS Fondazione del Piemonte per l'Oncologia Istituto per la Ricerca e la Cura del Cancro di Candiolo, Candiolo

Szpital Pomorski Im. PCK, Gdynia

Maria Sklodowska Curie National Research Institute of Oncology, Warsaw

Hospital Universitario Fundación Jiménez Díaz, Madrid

Hospital Universitario Virgen de La Victoria, Málaga

Hospital Universitario de Canarias, San Cristóbal de La Laguna

Hospital Universitario Donostia, San Sebastián

Hospital Clínico Universitario de Valencia, Valencia

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

All Listed Sponsors
lead

Philogen S.p.A.

INDUSTRY

NCT04733183 - Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma | Biotech Hunter | Biotech Hunter