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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
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Münster, Münster, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Name: Filippo De Braud, Dr
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Christoph Schliemann, Dr
Affiliation: Universitätsklinikum Münster
Role: PRINCIPAL_INVESTIGATOR