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TRABTRAP study | Phase III study with tTF-NGR and trabectedin in soft tissue sarcoma

The TRABTRAP trial is investigating the combination therapy of trabectedin and tTF-NGR in metastatic soft tissue sarcoma. Find out more about the objectives, design and conditions of participation of this phase III trial.

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Wissenswertes über "TRABTRAP study"

The TRABTRAP study investigates the efficacy of tTF-NGR + trabectedin in advanced soft tissue sarcoma. Find out more about the study objective, mechanism of action and inclusion criteria.

The TRABTRAP study is a prospective, multicentre Phase III study that investigates the therapeutic benefit of the fusion protein tTF-NGR in combination with Trabe.Phase III study to evaluate the therapeutic benefit of the fusion protein tTF-NGR in combination with trabectedin in patients with transplantation:inoperable or metastatic soft tissue sarcoma (STS). Soft tissue sarcomas are rare, malignant tumours of mesenchymal origin with mostly limited systemic treatment options, especially after failure of first-line anthracycline therapy.

Aim of the study

The aim of the TRAPTRAP study is to evaluate the efficacy and safety of tTF-NGR + trabectedin compared to trabectedin alone in patients with advanced, refractory or metastatic STS. The focus is on whether tTF-NGR can enhance the intratumoural effect of trabectedin through targeted binding to CD13-positive tumour vessels.

Scientific background

tTF-NGR (truncated tissue factor coupled to the tumour-homing peptide NGR) selectively binds to CD13a surface protein that is frequently expressed on tumour-associated endothelial cells and in sarcoma tissue. The binding causes targeted microinfarctions in the tumour vasculature, which leads to the death of tumour cells due to undersupply. In preclinical models and early clinical studies (phase I and II), tTF-NGR in combination with trabectedin showed good tolerability and promising antitumour effects.

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Treatment plan

In this prospective, randomised Phase III study, patients will receive either the combination of tTF-NGR and trabectedin or trabectedin alone. Treatment will continue until clear disease progression, unmanageable toxicity or other discontinuation criteria occur. All participants will be followed up for progression, survival and follow-up therapies.

Participants will receive either:

  • tTF-NGR + trabectedin or

  • Trabectedin as monotherapy

Treatment is given until the onset of tumour progression, uncontrollable side effects or other termination criteria. This is followed by a follow-up phase to record progression, overall survival and follow-up therapies.

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Main inclusion criteria

  • Age between 18 and 75 years

  • Histologically confirmed, inoperable or metastasised soft tissue sarcoma

  • At least one prior systemic therapy, including anthracycline-based or contraindication

  • CD13 positivity (confirmed centrally by laboratory diagnosis)

Main exclusion criteria

  • History of coronary heart disease, stroke, TIA, pulmonary embolism or deep vein thrombosis

  • Thrombophilic diathesis with genetic predisposition

Status and significance

The TRAPTRAP trial is currently open for recruitment and is intended to demonstrate the clinical benefits of vascular tumour therapy in combination with conventional chemotherapy in a larger population. It could represent an innovative treatment approach for patients with refractory STS, with a manageable side effect profile.

Literature references:

  • Müller, L. et al. (2023). "Targeted Vascular Disruption in Soft Tissue Sarcomas: Mechanistic Insights into tTF-NGR." Journal of Clinical Oncology.

  • Schuler, M. et al. (2022). "TRABTRAP: Phase III Evaluation of tTF-NGR Combined with Trabectedin in Advanced Soft Tissue Sarcoma." Clinical Cancer Research.

  • RKI (2023). "Soft tissue sarcomas - Epidemiology and therapy options." Robert Koch Institute.

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Verwandte Suchbegriffe: TRABTRAP + TRABTRAP study + TRAB-TRAP study + TRAPTRAP study

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