A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
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
Checked against the public recordLast updated Dec 13, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Other: NZV930; Other: PDR001; Drug: NIR178
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- H Lee Moffitt Cancer Center and Research Institute IncTampa, Florida
- University of Texas MD Anderson Cancer Center MD Anderson PSCHouston, Texas
- Novartis Investigative SiteMelbourne, Victoria
- Novartis Investigative SiteToronto, Ontario
- Novartis Investigative SiteMontreal, Quebec
- Novartis Investigative SiteChuo Ku, Tokyo
- Novartis Investigative SiteSingapore
- Novartis Investigative SiteValencia, Valencia
- Novartis Investigative SiteMadrid
- Novartis Investigative SiteSutton, Surrey
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 13, 2024. Always confirm current availability with the study team.