Clinical Trial 19684

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03549000

Phase: Phase I
Principal Investigator: Chiappori, Alberto

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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

This is a First In Human study of NZV930 to characterize the safety, tolerability, PK, PD and antitumor activity of NZV930 as a single agent and in combination with PDR001 and/or NIR178 in adult patients with advanced malignancies.

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.

Treatments

Therapies

Immunotherapy

Medications

NIR178 (); NZV930 (); PDR001 (Spartalizumab)

Inclusion Criteria

Inclusion Criteria:

Man and women aged 18 or older

Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy, and metastatic disease) with documented progression following standard therapy, or for whom, in the opinion of the Investigator, no appropriate standard therapy exists. Disease must be measurable as determined by RECIST 1.1 Escalation: Patients with advanced NSCLC, TNBC, PDAC, RCC, ovarian cancer, MSS CRC and mCRPC; no restrictions on the number of prior treatments

Expansion: Patients with advanced malignancies having received up to 3 lines of prior treatment. Indications will be determined by observed clinical activity in the dose escalation part and/or available literature

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. Exceptions may be considered after documented discussion with Novartis. Refer to Section 7.1.1 for further details regarding biopsy requirements. At screening, the submission of a recent biopsy sample is permitted if the following 3 conditions are met: (1) Biopsy was collected ≤ 3 months before screening (2) No immunotherapy was given to the patient since collection of biopsy. (3) Biopsy sample is present at site prior to 1st dose of study treatment

ECOG performance status 0-2 and in the opinion of the investigator likely to complete at least 56 days of treatment.

Other criteria may apply

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

Other exclusions may apply

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