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Sponsor: Pfizer
Conditions: Solid Tumors, Mycosis Fungoides, Melanoma, Merkel-cell Carcinoma, Squamous Cell Carcinoma
Interventions: TTI-621 Monotherapy, TTI-621 + PD-1/PD-L1 Inhibitor, TTI-621 + pegylated interferon-α2a, TTI-621 + T-Vec, TTI-621 + radiation
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Duarte, California, United States
- New York, New York, United States
- New York, New York, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States