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

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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

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Universitätsklinikum Münster, Münster, , Germany

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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