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Clinical Trial Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid malignancies.

Clinical Trial Description

This is an open-label, multi-center, sequential groups, dose escalation study of TAB08 in patients with metastatic or unresectable advanced solid malignancies. The study will consist of 2 parts: a dose-escalation part with a standard "3+3" design, followed by a dose-expansion part once the maximum tolerated dose (MTD) has been determined.

Patients must have documented recurrent or refractory solid tumors; patients enrolled in the dose-expansion part of the trial must have least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent, patients will be screened for entry into the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03006029
Study type Interventional
Source Theramab LLC
Contact Daniil G Nemenov, MD
Phone +74959747401
Email [email protected]
Status Recruiting
Phase Phase 1
Start date February 8, 2017
Completion date July 2020

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