A Study of DF6002 Alone and in Combination With Nivolumab
NCT ID: NCT04423029
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
438 participants
INTERVENTIONAL
2020-07-13
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation / Monotherapy / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
DF6002
Specified dose on specified days
Dose Escalation / Combination / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
DF6002
Specified dose on specified days
Nivolumab
Specified dose on specified days
Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
DF6002
Specified dose on specified days
Safety/PK/PD / Combination / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
DF6002
Specified dose on specified days
Nivolumab
Specified dose on specified days
Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma
Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W
DF6002
Specified dose on specified days
Nivolumab
Specified dose on specified days
Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma
Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W
DF6002
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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DF6002
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dragonfly Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Dragonfly Therapeutics
Locations
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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
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
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Gustave Roussy
Villejuif, , France
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Jennifer Valerin, MD
Role: primary
Mario Sznol, MD
Role: primary
Jose Lutzky, MD
Role: primary
Sharad Ghamande, MD
Role: primary
Dipesh Uprety, MD
Role: primary
Arkadiusz Dudek, MD
Role: primary
Eric Whitman
Role: primary
Jinyu Lu, MD
Role: primary
Jorge Garcia, MD
Role: primary
Benedito Carneiro, MD
Role: primary
Meredith McKean, MD
Role: primary
Hussein Tawbi, MD
Role: primary
Siwen Hu-Lieskovan, MD
Role: primary
Alexander Spira, Site 0015
Role: primary
Other Identifiers
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2023-510511-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DF6002 - 001
Identifier Type: -
Identifier Source: org_study_id
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