TerminatedPhase 1

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

United States56 participantsStarted 2016-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Optimal TTI-621 delivery regimen

Timeframe: 10 months

Trial details

NCT IDNCT02890368

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-31

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