A Study of DF6002 Alone and in Combination With Nivolumab

Last updated: January 28, 2025
Sponsor: Dragonfly Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Treatment

DF6002

Nivolumab

Clinical Study ID

NCT04423029
DF6002 - 001
2021-000038-33
2023-510511-19
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Advanced/metastatic solid tumors, for which no standard therapy exists or standardtherapy has failed among the following tumor types: melanoma, non-small cell lungcancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric,esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cellcarcinoma, 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 assessedby Investigator as being at high risk for venous thromboembolism (VTE) or history ofVTE ≥ 6 months from enrollment

Exclusion

Exclusion Criteria:

  • Concurrent anticancer treatment (with the exception of palliative bone directedradiotherapy), immune therapy, or cytokine therapy (except for erythropoietin),major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy withsteroids or other immunosuppressive agents, or use of any investigational drugwithin 28 days before the start of study treatment

  • Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directedtherapy, 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 hereditarythrombophilia

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 438
Treatment Group(s): 2
Primary Treatment: DF6002
Phase: 1
Study Start date:
July 13, 2020
Estimated Completion Date:
November 30, 2027

Study Description

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.

Connect with a study center

  • Local Institution - 0023

    Box Hill, 3128
    Australia

    Site Not Available

  • Local Institution - 0022

    Heidelberg, 3084
    Australia

    Site Not Available

  • Local Institution

    Paris, Ile-de-France 75010
    France

    Active - Recruiting

  • Local Institution

    Pierre-Bénite, Rhone 69495
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux Cedex, 33000
    France

    Active - Recruiting

  • Local Institution - 0026

    Bordeaux Cedex, 33000
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Active - Recruiting

  • Local Institution - 0002

    Paris, 75010
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Local Institution - 0027

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Local Institution - 0001

    Villejuif, 94805
    France

    Active - Recruiting

  • Local Institution

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Local Institution - 0029

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Local Institution

    Madrid, 28034
    Spain

    Active - Recruiting

  • Local Institution - 0028

    Madrid, 28040
    Spain

    Active - Recruiting

  • Local Institution - 0030

    Madrid, 28034
    Spain

    Active - Recruiting

  • Local Institution - 0031

    Madrid, 28027
    Spain

    Active - Recruiting

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Local Institution - 0025

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Local Institution

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • SCRI - HealthOne Denver

    Denver, Colorado 80218
    United States

    Site Not Available

  • Local Institution

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale School of Medicine

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Local Institution

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Augusta University Georgia Cancer Center

    Augusta, Georgia 30912-0003
    United States

    Active - Recruiting

  • Local Institution

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Local Institution

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Local Institution

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Local Institution

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Local Institution

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Local Institution

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • Local Institution

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Local Institution

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Local Institution

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Local Institution

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • SCRI - Tennessee Oncology - Saint Thomas West Clinic

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Local Institution

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute and Hospital

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Local Institution

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Local Institution

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • USOR - Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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