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

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Pfizer

Status and phase

Terminated
Phase 1

Conditions

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

Treatments

Drug: TTI-621 + PD-1/PD-L1 Inhibitor
Drug: TTI-621 Monotherapy
Other: TTI-621 + radiation
Other: TTI-621 + T-Vec
Drug: TTI-621 + pegylated interferon-α2a

Study type

Interventional

Funder types

Industry

Identifiers

NCT02890368
TTI-621-02

Details and patient eligibility

About

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.

Full 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 (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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 7 patient groups

TTI-621 Monotherapy Escalation
Experimental group
Description:
TTI-621 Escalation phase of single or multiple doses of TTI-621 delivered by intratumoral injections (various dose cohorts).
Treatment:
Drug: TTI-621 Monotherapy
TTI-621 Monotherapy (Single Lesion)
Experimental group
Description:
TTI-621 Single Lesion Injection Expansion Cohort
Treatment:
Drug: TTI-621 Monotherapy
TTI-621 Monotherapy (Multiple Lesions)
Experimental group
Description:
TTI-621 Multiple Lesion Injections Expansion Cohort
Treatment:
Drug: TTI-621 Monotherapy
TTI-621 + PD-1/PD-L1 Inhibitor
Experimental group
Description:
Combination Therapy Expansion Cohort of TTI-621 plus PD-1/PD-L1 Inhibitor
Treatment:
Drug: TTI-621 + PD-1/PD-L1 Inhibitor
TTI-621 + Pegylated Interferon-α2a
Experimental group
Description:
Combination Therapy Expansion Cohort of TTI-621 plus Pegylated Interferon-α2a
Treatment:
Drug: TTI-621 + pegylated interferon-α2a
TTI-621 + T-Vec
Experimental group
Description:
Combination Therapy Expansion Cohort of TTI-621 plus T-Vec
Treatment:
Other: TTI-621 + T-Vec
TTI-621 + Radiation
Experimental group
Description:
Combination Therapy Expansion Cohort of TTI-621 plus Radiation Therapy
Treatment:
Other: TTI-621 + radiation

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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