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

Stopped early · Phase 1

Conditions studied: Solid Tumors, Mycosis Fungoides, Melanoma, Merkel-cell Carcinoma, Squamous Cell Carcinoma, Breast Carcinoma, Human Papillomavirus-Related Malignant Neoplasm, Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT02890368

Run by

Pfizer

People needed

56

Starts

2016-09-01

Expected to finish

2020-03-31

Last updated by the study team

2023-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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