Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid tumors not amenable of standard therapies.

Safety will be established by clinical and laboratory assessment according to NCI-CTCAE criteria (version 4.02).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGC Biologics S.p.A.; MolMed S.p.A.

Criteria

Inclusion Criteria:

• Patients ≥18 years with selected metastatic solid tumours recognized to be highly vascularised and not amenable to any clinical improvement by current standard treatments

• Colorectal cancer (CRC) patients previously resistant to standard systemic regimens (including biologic agents)

• Gastric cancer (GC) patients treated with no more than two standard systemic regimens for metastatic disease

• Hepatocellular carcinoma (HCC) patients previously resistant to standard systemic regimens

• Pancreatic carcinoma (PC) patients treated with no more than one standard systemic regimen for metastatic disease

• Non small cell lung carcinoma (NSCLC) patients treated with no more than two standard systemic regimens (including biologic agents) for metastatic disease

• Neuroendocrine (NE) tumours refractory to somatostatin analogue treatment

• Other rare tumours including malignant pleural mesothelioma (MPM), soft-tissue sarcoma (STS), and renal cell carcinoma (RCC), resistant/refractory to current standard treatments

• Life expectancy more than 3 months

• ECOG Performance status 0-1

• Adequate baseline bone marrow, hepatic and renal function, defined as follows:

• Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L

• Bilirubin <1.5 x ULN

• AST and/or ALT <2.5 x ULN in absence of liver metastasis

• AST and/or ALT <5 x ULN in presence of liver metastasis

• Serum creatinine <1.5 x ULN

• Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min

• Patients may have had prior therapy providing the following conditions are met before treatment start:

• Chemotherapy, radiation therapy, hormonal therapy, or immunotherapy: wash-out period of 28 days

• Surgery: wash-out period of 14 days

• Patients must give written informed consent to participate in the study.

Exclusion Criteria:

• Concurrent anticancer therapy

• Patients must not receive any other investigational agents while on study

• Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication

• Uncontrolled hypertension

• Prolonged QTc interval (congenital or acquired) > 450 ms

• Patient with significant peripheral vascular disease

• History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy), or history of stroke

• Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol

• Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

• Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.