tTF-NGR Randomized Study - STS

PHASE3RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

October 26, 2021

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Trabectedin

Patients will receive standard trabectedin 1.5 mg/m2 as a 24-hour central intravenous (IV) infusion on day 1, q d 22 x until disease progression or contraindications against further application.

BIOLOGICAL

tTF-NGR

Patients will receive standard trabectedin according to arm 1 plus 0.5 mg/m2 of tTF-NGR (1-hour ratecontrolled infusion, port central venous access, 0.9 % NaCl ad 100 mL) on days 2 and 3 following each trabectedin cycle (within 1 hour interval between end of trabectedin infusion and tTF-NGR: e.g.: trabectedin on monday 8 am to tuesday 8 am followed by tTF-NGR on tuesday 9 am and on the following day, q d 22 x until disease progression or contraindications against further application.

Trial Locations (9)

13125

RECRUITING

HELIOS Klinikum Berlin-Buch, Berlin

15529

RECRUITING

HELIOS Klinikum Bad Saarow, Bad Saarow

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

48149

RECRUITING

University Hospital Muenster, Germany, Münster

55131

RECRUITING

Universitätsmedizin Mainz, Mainz

69120

RECRUITING

Universitätsklinikum Heidelberg, Heidelberg

81377

RECRUITING

LMU Klinikum, Münich

81675

RECRUITING

Klinikum rechts der Isar der technischen Universität München, München

01307

RECRUITING

TU Dresden Medizinische Fakultät Carl Gustav Carus, Dresden

Sponsors
All Listed Sponsors
collaborator

Anturec Pharmaceuticals GmbH

UNKNOWN

lead

Universität Münster

OTHER

NCT05597917 - tTF-NGR Randomized Study - STS | Biotech Hunter | Biotech Hunter