Spots Global Cancer Trial Database for L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid Tumours

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid Tumours

Official Title: Phase I Study of the Tumor-targeting Human L19TNFα Monoclonal Antibody-cytokine Fusion Protein in Combination With Doxorubicin in Patients With Advanced Solid Tumours

Study ID: NCT02076620

Conditions

Advanced Solid Tumors Amenable to Anthracycline Therapy

Sarcoma, Breast Cancer, Lung Carcinomas, and Gynecological Cancer Amenable to Anthracycline Therapy

Interventions

L19TNFα

Doxorubicin

Study Description

Brief Summary: Prospective, open-label, non randomized, dose escalation study that will be conducted in sequential cohorts of patients.

Detailed Description: In the clinical trial 3-6 patients will be assigned to L19TNFalfa at one of the following sequential dose levels (10.4 µg/kg, 13 µg/kg and 17 µg/kg) in combination with a fixed dose of doxorubicin. The RD will be defined following a traditional 3+3 design. The dose escalation will continue until the MTD is found, that is until at least two patients among a cohort of three to six patients experience a dose limiting toxicity (DLT).