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A Study of DF6002 Alone and in Combination With Nivolumab
Trial Status: active
The purpose of this study is to evaluate the safety, tolerability, drug-levels,
drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with
Nivolumab in participants with advanced solid tumors.
Inclusion Criteria
Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
ECOG performance status of 0 or 1
Clinical or radiological evidence of disease
Adequate hematological, hepatic and renal function
Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment
Exclusion Criteria
Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment
Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety
Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
Rapidly progressive disease
Serious cardiac illness or medical conditions
Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia Other protocol-defined inclusion/exclusion criteria apply
Additional locations may be listed on ClinicalTrials.gov for NCT04423029.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV)
administration of DF6002, as monotherapy and in combination with nivolumab, and to
determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED)
of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients
with advanced (unresectable, recurrent, or metastatic) solid tumors.
