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Clinical Trial 19684

Cancer Type: Thoracic
Interventions:NIR178; NZV930; PDR001 (Spartalizumab)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase I/Ib, Open-Label, Multi-Center Study of NZV930 as a Single Agent and in Combination with PDR001 and/or NIR178 in Patients with Advanced Malignancies

Summary

Objective

Primary Objectives To characterize the safety and tolerability of NZV930 as a single agent and in combination with PDR001 and/or NIR178 in patients with advanced malignancies. To determine the recommended dose (RD) for expansion for single agent NZV930 and in combinations with PDR001 and/or NIR178 Secondary Objectives To assess the preliminary anti-tumor activity of NZV930 as a single agent and in combination with PDR001 and/or NIR178 To characterize the pharmacokinetics (PK) of NZV930 as a single agent and in combination with PDR001 and/or NIR178 To assess the immunogenicity of NZV930 and PDR001 ¿h To characterize changes in the immune infiltrate in tumors following the administration of NZV930 as a single agent and in combination with PDR001 and/or NIR178.

Inclusion Criteria

  • Adult men & women ≥ 18 years of age Histologically confirmed advanced malignancies with documented progression following standard therapy, or for whom, in the opinion of the investigator, no appropriate standard therapy exists.
  • Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.
  • ECOG performance status 0-2 and in the opinion of the investigator, likely to complete at least 56 days of treatment.

  • Exclusion Criteria

  • Symptomatic or uncontrolled Brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
  • Patients with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment prior to study entry and at doses of ≤10 mg per day prednisolone or equivalent for at least 2 weeks before administration of any study treatment.
  • Patients who required discontinuation of treatment due to treatment-related toxicities with prior immunotherapy.
  • Patients previously treated with anti-CD73 treatment and/or adenosine receptor A2a (A2aR) inhibitors.
  • Active, previously documented, or suspected autoimmune disease within the past 2 years.
  • Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded. Additionally, patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
  • History of or current drug-induced interstitial lung disease or pneumonitis grade ≥ 2.
  • Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia Patients with corrected QT using the Fridericia's correction (QTcF) > 470 msec for females or >450 msec for males, on screening ECG or congenital long QT syndrome Acute myocardial infarction or unstable angina >Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 6 weeks is indicated as washout period. For patients receiving anticancer immunotherapies, 4 weeks is indicated as the washout period.
  • Systemic chronic steroid therapy (≥ 10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, nasal, and ophthalmic steroids are allowed