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Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms

2019-07-10 15:08:33 | BioPortfolio

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.

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

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Solid Tumors

Intervention

TAB08

Status

Not yet recruiting

Source

Theramab LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-10T15:08:33-0400

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