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

Pfizer7 sites in 1 country56 target enrollmentSeptember 2016

ConditionsSolid Tumors Mycosis Fungoides Melanoma Merkel-cell Carcinoma Squamous Cell Carcinoma Breast Carcinoma Human Papillomavirus-Related Malignant Neoplasm Soft Tissue Sarcoma

InterventionsTTI-621 Monotherapy TTI-621 + PD-1/PD-L1 Inhibitor TTI-621 + pegylated interferon-α2a TTI-621 + T-Vec TTI-621 + radiation

DrugsTTI-621 Monotherapy TTI-621 + PD-1/PD-L1 Inhibitor TTI-621 + pegylated interferon-α2a

Overview

Phase: Phase 1
Intervention: TTI-621 Monotherapy
Conditions: Solid Tumors
Sponsor: Pfizer
Enrollment: 56
Locations: 7
Primary Endpoint: Optimal TTI-621 delivery regimen
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in patients that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. TTI-621 (SIRPα-IgG1 Fc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (antiphagocytic) signal to macrophages. The study will be performed in two different parts: Dose Escalation and Dose Expansion. During the escalation part of the study, TTI-621 was studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose (MTD). During the expansion part of the study, TTI-621 will be studied in an expanded group of patients at the maximum feasible dosing regimen determined in the escalation phase. After completion of their initial assigned therapy, subjects may receive continuation with TTI-621. The expansion phase will further define safety and characterize efficacy of TTI-621 alone and in combination with other anti-cancer therapies.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

March 31, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility 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