OncoMatch/Clinical Trials/NCT05597917
tTF-NGR Randomized Study - STS
Is NCT05597917 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including tTF-NGR and Trabectedin for soft tissue sarcoma.
Treatment: Trabectedin · tTF-NGR — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: ANPEP positivity with a score of ≥ 1 (20) by central pathology (score ≥ 1 (20))
CD13 positivity with a score of ≥ 1 (20) by central pathology (GDI Münster)
Disease stage
Metastatic disease required
Grade: 23 (FNCLCC)
high-grade advanced unresectable or metastatic soft tissue sarcoma (grade 2 - 3) according to the FNCLCC grading system
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline — first line or adjuvant within 12 months
after failure of anthracycline-containing first line therapy (or anthracycline-containing adjuvant therapy within 12 months before entry on study) or with contraindications to these drugs
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L, platelets ≥ 50 x 10^9/L (for trabectedin ≥ 100 x 10^9/L, investigator discretion), Hb ≥ 8.0 g/dl
Kidney function
creatinine < 2.0 x ULN; no chronically impaired renal function
Liver function
ALT, AST, ALP or total bilirubin < 2.5 x ULN unless due to liver metastasis (decision by the investigator)
no adequate bone marrow function, absolute neutrophil count (ANC) < 1.0 x 10^9/L, platelets < 50 x 10^9/L (for trabectedin actually < 100 x 10^9/L - to be decided by the investigator on an individual patient basis) and haemoglobin (Hb) < 8.0 g/dl. chronically impaired renal function or creatinine ≥ 2.0 x upper limit of normal (ULN). inadequate liver function (alanine aminotranserase (ALT), aspartate aminotranserase (AST), alkaline phosphatase (ALP) or total bilirubin ≥ 2.5 x ULN) unless due to liver metastasis (decision by the investigator)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify