Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug

This is a phase I, open-label, dose escalation study with Angiocal® in patients with solid tumors using a group sequential adaptive treatment assignment. Patients will be allocated to different dose levels in small cohorts and will receive one single dose application on Day 1, followed by a repeated dosing period. The primary objective of the study is to evaluate the safety and tolerability of Angiocal® when administered intravenously to patients with solid tumors. The secondary objectives of the study are the characterization of the pharmacodynamic response, evaluation of the pharmacokinetic profile of Angiocal®, observation of tumor response.

Inclusion criteria

• Males or females with advanced, recurrent or metastatic cancer, refractory to standard therapy;
• Age ≥18 years;
• Signed informed consent form and ability to understand the study procedures.

Exclusion criteria

• Concomitant anticancer therapy, including radiation;
• Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study;
• Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day);
• Chronic daily treatment with corticosteroids, with the exception of inhaled steroids;
• Inadequate bone marrow function;
• Inadequate liver function;
• Inadequate renal function;
• Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) >1.5 or an activated partial thromboplastin time (aPTT) >1.5 x ULN within 7 days prior to first study treatment;
• Patients with lymphomas;
• Evidence of spinal cord compression or brain metastases;
• Other malignancy diagnosed within the previous 5 years;
• Pregnant or lactating females.;
• All patients who do not use a highly effective method of birth control;
• Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment;
• Minor surgical procedures, within 24 hours prior to the first study treatment;
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding;
• Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease;
• History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra-abdominal abscess within 6 months of enrollment;
• Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel;
• Serious non-healing wound, peptic ulcer or bone fracture;
• Known hypersensitivity to the study medication or any of its excipients;
• Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications;
• Previous enrollment in this study;
• Known hepatitis B or C or HIV infection;
• Employees of the sponsor or patients who are employees or relatives of the investigator.