Last updated on September 2017

Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides


Brief description of study

This is a multicenter, open-label, phase 1 study that is being done to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621.

Detailed Study Description

This is a multicenter, open-label, phase 1 study that is being done to test intratumoral injections of TTI-621 in patients that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts: Dose Escalation and Dose Expansion. During the escalation part of the study, TTI-621 will be studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose (MTD). During the expansion part of the study, TTI-621 will be studied in an expanded group of patients at the dose and frequency which had acceptable level of side effects during the escalation part of the study. The expansion phase will further define safety and characterize efficacy. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621.

Clinical Study Identifier: NCT02890368

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Jaemee Bautista

City of Hope National Medical Center
Duarte, CA United States
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Melody Erickson

Oregon Health & Science University
Portland, OR United States
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Sue McCann

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Meghan Irwin

University of Washington - Seattle Cancer Care Alliance
Seattle, WA United States
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