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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 1 Dose Escalation Trial of Intratumoral Injections of TTI-621 in Subjects with Relapsed and Refractory Percutaneously Accessible Solid Tumors and Mycosis Fungoides

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT02890368

Background Information

TTI-621 is a type of protein called a fusion protein which is similar to an antibody. It is designed to target and block a protein called CD47. CD47 is present on cancer cells and is used by cancer cells to hide from your body’s immune system. Blocking CD47 with TTI-621 may help your body’s immune system find and destroy the cancer cells. This study is also being done to understand how the body absorbs and processes different doses of TTI-621 by measuring the levels of the study drug in the blood at different times. This is called pharmacokinetics (PK) testing. This study is also being conducted to understand how TTI-621 affects the body, such as its effect on the immune system; and to understand the side effects and possible benefit when TTI-621 is given alone and also together with different FDA approved anti-cancer treatments.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Histologically- or cytologically-documented cancer (limited to solid tumors, plasmacytoma, and cutaneous lymphoma), with at least one injectable lesion
  • Additional eligibility in protocol

Ineligibility Information

  • Active, untreated, known central nervous system disease involvement. Any brain metastases must have been stable for 28 days prior to enrollment.
  • Significant cardiovascular disease such as symptomatic congestive heart failure (New York Heart Association Class III or IV), symptomatic coronary artery disease, myocardial infarction within the last 6 months, unstable arrhythmia requiring treatment, unstable angina, or prolonged QTc interval > 480 milliseconds (Grade 2 or higher)
  • Active graft-versus-host disease (GVHD) with the exception of Grade 1 skin involvement (i.e., maculopapular rash < 25% of body surface)
  • History of hemolytic anemia or bleeding diathesis
  • Additional exclusions in protocol