TTI-621-02 (NCT02890368)

This study is currently recruiting patients. For more information, including a list of trial locations, please refer to clinicaltrials.gov.

TTI-621-02 (NCT02890368) is a multicenter, open-label phase 1 trial that is testing intratumoral injections of TTI-621 in subjects with relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides (a form of cutaneous T cell lymphoma). The study is being performed in two parts. In the dose escalation phase, TTI-621 is being studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose. During the expansion phase, TTI-621 will be studied in larger cohorts of patients at the optimal dose and frequency. The expansion phase will further define safety and characterize efficacy. Detailed evaluation of serial, on-treatment tumor biopsies of both injected and non-injected cancer lesions will help characterize tumor microenvironment changes anticipated with CD47 blockade. We believe the study of TTI-621 delivered by intratumoral injections could lead to a more thorough understanding of its mechanism of action and could provide insight into the tumor micro-environment before, during and after treatment with TTI-621.

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