Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Breast Neoplasms

Sarcoma

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Only one arm is specified. Patients will be treated in three cohorts with 3 different dosages of L19TNFα in combination with 60 mg/m2 of doxorubicin, according to the following study design:

cohort 1 --\> 10.4 μg/kg L19TNFα + doxorubicin; cohort 2 --\> 13 μg/kg L19TNFα + doxorubicin; cohort 3 --\> 17 μg/kg L19TNFα + doxorubicin.

L19TNFα will be administered as a 2 hours i.v. infusion on days 1, 3, and 5 of each 3-week cycle.

L19TNFα

Doxorubicin will be administered as a 15 minutes i.v. infusion on day 1 of each 3-week cycle prior L19TNFα administration.

Filippo De Braud, Dr

Christoph Schliemann, Dr

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

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).

L19TNFα in Combination With Doxorubicin in Patients With Advanced Solid Tumours

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

To assess the safety, including maximum tolerated dose (MTD), recommended dose (RD) and dose limiting toxicity (DLT) of L19TNFα in combination with doxorubicin, the following will be considered:

* Adverse Events (AEs) assessment based on CTCAE v.4.03, including DLT assessment.
* Standard laboratory (haematology, biochemistry and urinalysis) parameters.
* Physical examination findings including assessment of vital signs and physical measurements (blood pressure, heart rate, body weight).

Investigate the potential induction of human anti-fusion protein antibodies (HAFA) through standard laboratory analysis.

Philogen S.p.A.

Spots Global Cancer Trial Database for sarcoma, breast cancer, lung carcinomas, and gynecological cancer amenable to anthracycline therapy