RecruitingPhase 3NCT05597917

tTF-NGR Randomized Study - STS

Phase III Study Comparing Trabectedin (T) Versus T Plus tTF-NGR to Entrap T Inside the Tumor in Patients With Metastatic and/or Refractory Soft Tissue Sarcoma (STS)

Sponsor

Universität Münster

Enrollment

126 participants

Start Date

Oct 26, 2021

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

Summary

In this phase III open label, controlled clinical trial patients with unresectable or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs and CD13 positivity in central histology (grade \>/= 1+) are treated to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy prolongs progression-free survival (according to iRECIST), as compared with trabectedin alone. Further objectives are to evaluate the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy with respect to the response rate and overall survival as well as to assess the safety profile of tTF-NGR combined with trabectedin. Before the randomized phase III part of the study, there was a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part is 0.5 mg/m2 per day for 2 consecutive days following each trabectedin infusion and is used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail. . Further dose modification for tTF-NGR is possible.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called tTF-NGR in people with advanced or metastatic soft tissue sarcoma (a type of cancer that affects muscles, fat, nerves, and connective tissue) whose cancer stopped responding to standard chemotherapy. The drug works by cutting off blood supply to tumors. **You may be eligible if...** - You are age 18 to 75 - You have advanced or metastatic soft tissue sarcoma - Your cancer no longer responds to standard chemotherapy that included a drug class called anthracyclines - Your overall health is reasonable enough to participate in a clinical trial **You may NOT be eligible if...** - You have certain types of sarcoma that are excluded from the study - You have significant heart, kidney, or blood problems - You are pregnant or breastfeeding - Your cancer has certain genetic profiles that make the study treatment unlikely to work Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrabectedin

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.

BIOLOGICALtTF-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.