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Clinical Trial 19858

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT03515551

Phase: Phase I/II
Prinicipal Investigator:

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Overview

Study Title

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A*0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer

Summary

IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.

Objective

Phase I Dose Escalation Cohorts: The primary objective of Phase I is to identify the MTD and/or the RP2D of IMCnyeso, as a monotherapy, when administered weekly to patients with advanced NSCLC, melanoma, urothelial cancer, and synovial sarcoma. Phase II Dose Expansion Cohorts: The primary objective of Phase II is to further explore the safety and tolerability of the identified RP2D of IMCnyeso in 3 patient populations: advanced NSCLC, urothelial cancer, and synovial sarcoma.

Treatments

Therapies

Medications

IMCnyeso ()

Inclusion Criteria

  • HLA-A*0201 positive
  • NY-ESO-1 and/or LAGE-1A positive tumor
  • ECOG PS 0 or 1
  • Selected advanced solid tumors
  • Relapsed from, refractory to, or intolerant of standard therapy
  • Measurable disease per RECIST v1.1
  • If applicable, must agree to use highly effective contraception

  • Exclusion Criteria

  • Symptomatic or untreated central nervous system metastasis
  • Inadequate washout from prior anticancer therapy
  • Significant ongoing toxicity from prior anticancer treatment
  • Impaired baseline organ function as evaluated by out-of-range laboratory values
  • Clinically significant cardiac disease
  • Active infection requiring systemic antibiotic therapy
  • Known history of human immunodeficiency virus (HIV)
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Ongoing treatment with systemic steroids or other immunosuppressive therapies
  • Significant secondary malignancy
  • Pregnant or lactating

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