OncoMatch/Clinical Trials/NCT05597917
tTF-NGR Randomized Study - STS
Is NCT05597917 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05597917 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anthracycline.
Does this trial require ANPEP?
Yes, ANPEP positivity with a score of ≥ 1 (20) by central pathology is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages