A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    344
  • sponsor
    Novartis Pharmaceuticals
Updated on 12 February 2022

Summary

The purpose of this study is to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers

Details
Condition Non-small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer Microsatellite Stable (MSS), Ovarian Cancer, Renal Cell Carcinoma (RCC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
Treatment PDR001, NIR178, NZV930
Clinical Study IdentifierNCT03549000
SponsorNovartis Pharmaceuticals
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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 < 3
months prior to study entry History of stroke or transient ischemic event requiring medical
therapy Symptomatic claudication Infection: HIV infection, Active HBV or HCV infection (per
institutional guidelines). Patients with chronic HBV or HCV disease that is controlled
under antiviral therapy are allowed in the expansion but not in the escalation, Known
history of tuberculosis Infection requiring systemic antibiotic therapy. Patients requiring
systemic antibiotics for infection must have completed treatment before screening is
initiated
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 protocol-defined inclusion/exclusion criteria may apply
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