The purpose of this study is to determine if Angiocal® (PRS-050-PEG40) is safe and well tolerated when it is injected into the veins of patients with solid tumors. Other purposes of this study are to investigate how the body of the patients reacts to Angiocal®, how the blood level of Angiocal® develops after injection and how the tumor responds to the injection of Angiocal®.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Single dose of Angiocal® i.v. (intravenous) on Day 1 and further applications of Angiocal® i.v. during a repeated dosing period.
Unnamed facility
Breisgau, Baden-Wurttemberg, Germany
Unnamed facility
Ruhrgebiet, North Rhine-Westphalia, Germany
Dose limiting toxicity
Dose limiting toxicity is determined by recording and evaluating adverse events / toxicity.
Time frame: Throughout the course of the study
Pharmacokinetic analysis
AUC\_0- τ; AUC\_0-tlast; AUC\_0-∞; C\_max; T\_max; t\_½; CL; V\_z; V\_ss; RA\_AUC; RA\_Cmax; RL; dose normalized values (norm) for AUC\_0-τ and C\_max will be determined by dividing the original toxicokinetic parameter by the dose level.
Time frame: Throughout the course of the study
Development of biomarkers in blood over time
Time frame: Throughout the course of the study
Response of target lesions over time
The objective tumor response for target lesions will be presented over time, employing the categories 'complete response', 'partial response, 'progressive disease´ and 'stable disease' and absolute changes.
Time frame: Throughout the course of the study
ECOG performance status
ECOG = Eastern Cooperative Oncology Group
Time frame: Throughout the course of the study
Clinical laboratory measures
Hematology, biochemistry, coagulation parameters, and urinalysis.
Time frame: Throughout the course of the study
Anti-drug antibodies
Time frame: Throughout the course of the study
Results of 12-lead Electrocardiogram by time point
Changes from the baseline visit will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate. Changes from the baseline visit in QTc between \>30 and \<60 ms and \>60 ms will be listed and summarized separately.
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Time frame: Throughout the course of the study
Changes of vital signs from the baseline visit
Heart rate, blood pressure and body temperature.
Time frame: Throughout the course of the study
Physical examination
Any changes in physical examination findings from baseline visit will just be summarized, since the physical examiniations will not result in measurable values.
Time frame: Throughout the course of the study