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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02890368
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Trillium Therapeutics Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors, Mycosis Fungoides, Melanoma, Merkel-cell Carcinoma, Squamous Cell Carcinoma, Breast Carcinoma, Human Papillomavirus-Related Malignant Neoplasm, Soft Tissue Sarcoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: TTI-621 Monotherapy Escalation

TTI-621 Escalation phase of single or multiple doses of TTI-621 delivered by intratumoral injections (various dose cohorts).

Experimental: TTI-621 Monotherapy (Single Lesion)

TTI-621 Single Lesion Injection Expansion Cohort

Experimental: TTI-621 Monotherapy (Multiple Lesions)

TTI-621 Multiple Lesion Injections Expansion Cohort

Experimental: TTI-621 + PD-1/PD-L1 Inhibitor

Combination Therapy Expansion Cohort of TTI-621 plus PD-1/PD-L1 Inhibitor

Experimental: TTI-621 + Pegylated Interferon-α2a

Combination Therapy Expansion Cohort of TTI-621 plus Pegylated Interferon-α2a

Experimental: TTI-621 + T-Vec

Combination Therapy Expansion Cohort of TTI-621 plus T-Vec

Experimental: TTI-621 + Radiation

Combination Therapy Expansion Cohort of TTI-621 plus Radiation Therapy

Interventions

Drug: - TTI-621 Monotherapy

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.

Drug: - TTI-621 + PD-1/PD-L1 Inhibitor

TTI-621 will be given in combination with one of the following programmed death-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitors: nivolumab, pembrolizumab, durvalumab, avelumab, or atezolizumab administered on Day 1. Subjects in this cohort must have a cancer diagnosis for which a PD-1/PD-L1 inhibitor is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.

Drug: - TTI-621 + pegylated interferon-α2a

TTI-621 will be given in combination with pegylated interferon-α2a. Subjects in this cohort must have a cancer diagnosis for which pegylated interferon-α2a is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.

Other: - TTI-621 + T-Vec

TTI-621 will be given in combination with talimogene laherparepvec (T-Vec). Subjects in this cohort must have unresectable melanoma.

Other: - TTI-621 + radiation

TTI-621 will be given following radiation to the target plasmacytoma. Subjects in this cohort must have relapsed multiple myeloma with bony or soft tissue plasmacytoma(s).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope National Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope National Medical Center

Duarte, California, 91010

Site Contact

Jaemee Bautista

jbautista@coh.org

626-218-3033

New York, New York

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016

Site Contact

Angela Tan

Angela.Tan@nyumc.org

646-501-7869

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Alexander Lesokhin

lesokhia@mskcc.org

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Knight Clinical Trials Information Line

theresa2@trilliumtherapeutics.com

503-494-1080

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237

Site Contact

Sue McCann

mccannsa@upmc.edu

412-864-3681

Inova Schar Cancer Institute, Fairfax, Virginia

Status

Recruiting

Address

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

Site Contact

Kelly Jeffords

Kelly.Jeffords@inova.org

571-472-0631

Seattle, Washington

Status

Recruiting

Address

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109

Site Contact

Shahaan Smith

sjsmith@seattlecca.org

206-606-6448

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