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

• Status: Terminated
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label, phase 1 study conducted 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. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trillium Therapeutics Inc.
• Treatments: Immune Checkpoint Inhibitors; Immunoglobulin G; Interferons; Talimogene laherparepvec

Criteria

Inclusion Criteria:

• Histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides)

• Adequate renal function

• Adequate coagulation function

• Adequate hepatic function

• Disease that has progressed on standard therapy or for whom there is no other therapy option available

Exclusion Criteria:

• Central nervous system involvement

• Significant cardiovascular disease

• Active autoimmune disease

• Active hepatitis B or C or a history of HIV infection

• Uncontrolled infection

• History of hemolytic anemia or bleeding diathesis