A Study of DF6002 Alone and in Combination With Nivolumab

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT04423029

Run by

Dragonfly Therapeutics

People needed

170

Starts

2020-07-13

Expected to finish

2025-11-26

Last updated by the study team

2026-03-18

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Irvine — Orange, California, United States
• SCRI - HealthOne Denver — Denver, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Augusta University Georgia Cancer Center — Augusta, Georgia, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Local Institution — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• HealthPartners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• SCRI - Tennessee Oncology - Saint Thomas West Clinic — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute and Hospital — Salt Lake City, Utah, United States
• USOR - Virginia Cancer Specialists - Fairfax Office — Fairfax, Virginia, United States
• Froedtert Hospital — Milwaukee, Wisconsin, United States
• Local Institution - 0023 — Box Hill, Australia
• Local Institution - 0022 — Heidelberg, Australia
• Institut Bergonié — Bordeaux, France
• Hôpital Saint-Louis — Paris, France

Full record on ClinicalTrials.gov

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