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

This is a multicenter, open-label, phase 1 study conducted to test intratumoral

injections of TTI-621 in patients that have relapsed and refractory percutaneously

accessible solid tumors or mycosis fungoides.

TTI-621 (SIRPα-IgG1 Fc) is a soluble recombinant fusion protein created by directly

linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the

Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and

preventing it from delivering an inhibitory "do not eat" (antiphagocytic) signal to

macrophages.

The study will be performed in two different parts: Dose Escalation and Dose Expansion.

During the escalation part of the study, TTI-621 was 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 maximum feasible dosing regimen determined in the escalation phase. After

completion of their initial assigned therapy, subjects may receive continuation with

TTI-621. The expansion phase will further define safety and characterize efficacy of

TTI-621 alone and in combination with other anti-cancer therapies.