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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TTI-621 Monotherapy Escalation

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

Group Type EXPERIMENTAL

TTI-621 Monotherapy

Intervention Type DRUG

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.

TTI-621 Monotherapy (Single Lesion)

TTI-621 Single Lesion Injection Expansion Cohort

Group Type EXPERIMENTAL

TTI-621 Monotherapy

Intervention Type DRUG

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.

TTI-621 Monotherapy (Multiple Lesions)

TTI-621 Multiple Lesion Injections Expansion Cohort

Group Type EXPERIMENTAL

TTI-621 Monotherapy

Intervention Type DRUG

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.

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

TTI-621 + Pegylated Interferon-α2a

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

Group Type EXPERIMENTAL

TTI-621 + pegylated interferon-α2a

Intervention Type DRUG

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.

TTI-621 + T-Vec

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

Group Type EXPERIMENTAL

TTI-621 + T-Vec

Intervention Type OTHER

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

TTI-621 + Radiation

Combination Therapy Expansion Cohort of TTI-621 plus Radiation Therapy

Group Type EXPERIMENTAL

TTI-621 + radiation

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

TTI-621 + T-Vec

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

Intervention Type 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).

Intervention Type OTHER

Other Intervention Names

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SIRPα-IgG1 Fc SIRPα-IgG1 Fc + PD-1/PD-L1 Inhibitor SIRPα-IgG1 Fc + pegylated interferon-α2a SIRPα-IgG1 Fc + talimogene laherparepvec SIRPα-IgG1 Fc + radiation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No