Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02890368
Status:
TERMINATED
Last Update Posted:
2023-04-05
First Post:
2016-08-26
Brief Title:
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 SIRPĪ±-IgG1 Fc is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPĪ± 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
TTI-621 SIRPĪ±-IgG1 Fc is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPĪ± 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None