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 14, 2022
  • participants needed
    344
  • sponsor
    Novartis Pharmaceuticals
Updated on 5 August 2021

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, Adenocarcinoma, Ovarian disorder, Malignant neoplasm of kidney, Breast Cancer, Ovarian Cancer, Renal Cell Carcinoma, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Ovarian Function, Pancreatic Ductal Adenocarcinoma, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Recurrent Ovarian Cancer, Metastatic Castration Resistant Prostate Cancer, Razor Bumps (Pseudofolliculitis Barbae), Colorectal Cancer Microsatellite Stable (MSS), Metastatic Triple-Negative Breast Cancer, Colorectal Cancer Microsatellite Stable (MSS), Kidney Cancer, Colorectal Cancer Microsatellite Stable (MSS), Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), clear cell renal cell carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, nsclc, ovarian tumors, Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS), Colorectal Cancer Microsatellite Stable (MSS)
Treatment PDR001, NIR178, NZV930
Clinical Study IdentifierNCT03549000
SponsorNovartis Pharmaceuticals
Last Modified on5 August 2021

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
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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