Clinical Trials /

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

NCT02890368

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.

Related Conditions:
  • Malignant Solid Tumor
  • Melanoma
  • Multiple Myeloma
  • Mycosis Fungoides
  • Plasmacytoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
TTI-621TTI-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

NameTypeDescriptionInterventions
TTI-621ExperimentalThe 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.
  • TTI-621

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