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

Stopped early · Phase 1

Conditions studied: 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)

In brief

The purpose of this study was 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

Key facts

Study ID

NCT03549000

Run by

Novartis Pharmaceuticals

People needed

127

Starts

2018-07-18

Expected to finish

2022-10-17

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• H Lee Moffitt Cancer Center and Research Institute Inc — Tampa, Florida, United States
• University of Texas MD Anderson Cancer Center MD Anderson PSC — Houston, Texas, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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