NCT03006029

Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms

A Phase 1b Multiple Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Theramab LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	TAB08	The initial dose of TAB08 will be 1 µg/kg TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle.

Timeline

• Start date: 2017-02-08
• Primary completion: 2019-05-14
• Completion: 2019-08-13
• First posted: 2016-12-30
• Last updated: 2021-10-06

Locations

1 site across 1 country: Russia