Description:
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.
Title
- Brief Title: Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
- 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
Clinical Trial IDs
- ORG STUDY ID:
TTI-621-02
- NCT ID:
NCT02890368
Conditions
- Solid Tumors
- Mycosis Fungoides
- Melanoma
- Merkel-cell Carcinoma
- Squamous Cell Carcinoma
- Breast Carcinoma
- Human Papillomavirus-Related Malignant Neoplasm
- Soft Tissue Sarcoma
Interventions
Drug | Synonyms | Arms |
---|
TTI-621 | TTI-621 (SIRPαFc) | TTI-621 |
Purpose
This is a multicenter, open-label, phase 1 study that is being done 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.
Detailed Description
This is a multicenter, open-label, phase 1 study that is being done to test intratumoral
injections of TTI-621 in patients that have relapsed and refractory percutaneously
accessible solid tumors or mycosis fungoides.
The study will be performed in two different parts: Dose Escalation and Dose Expansion.
During the escalation part of the study, TTI-621 will be 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 dose and frequency which had acceptable level of side effects during the
escalation part of the study. The expansion phase will further define safety and
characterize efficacy.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
TTI-621 | Experimental | The Escalation Phase will include single or multiple doses of TTI-621 delivered by intratumoral injections followed by the Expansion Phase during which one or more selected dose levels of TTI-621 will be tested. | |
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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicity (DLT) |
Time Frame: | 1 month |
Safety Issue: | |
Description: | Number of participants with a DLT |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Trillium Therapeutics Inc. |
Trial Keywords
- CD47
- SIRPa
- Immunotherapy
- Checkpoint inhibitor
Last Updated
February 13, 2017