tTF-NGR Phase I Study

Summary

In this phase I clinical trial cancer patients suffering from solid tumors or lymphomas, recurring after and/or refractory against standard treatment are treated intravenously (iv) with increasing doses of tTF-NGR(tTF= truncated tissue factor; NGR=Asn-Gly-Arg). The objectives of this trial are to evaluate the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of intravenously (iv) infused daily applications of tTF-NGR for 5 days every 3 weeks in patients with cancer, who had obtained all standard treatment known for their disease entity prior to entry on study. Further objectives are to determine the perfusion and vascular volume fraction of measurable tumor lesions versus normal reference tissue before and after tTF-NGR application by MRI as a biological surrogate parameter for biological activity of the investigational medicinal product (IMP), tTF-NGR, and to obtain pharmacokinetic data.

Timeline

Start

2017-03-01

Primary completion

2019-11-05

Completion

2019-11-05

Publications

• Results Schliemann C, Gerwing M, Heinzow H, Harrach S, Schwoppe C, Wildgruber M, Hansmeier AA, Angenendt L, Berdel AF, Stalmann U, Berning B, Kratz-Albers K, Middelberg-Bisping K, Wiebe S, Albring J, Wilms C, Hartmann W, Wardelmann E, Krahling T, Heindel W, Gerss J, Bormann E, Schmidt H, Lenz G, Kessler T, Mesters RM, Berdel WE. First-In-Class CD13-Targeted Tissue Factor tTF-NGR in Patients with Recurrent or Refractory Malignant Tumors: Results of a Phase I Dose-Escalation Study. Cancers (Basel). 2020 Jun 7;12(6):1488. doi: 10.3390/cancers12061488.

Drugs

Indications