A Study of DF6002 Alone and in Combination With Nivolumab

NCT04423029 | Completed Phase 1 FDA Drug

• 2 other identifiers: DF6002 - 0012023-510511-19
• Study Type: interventional
• Target: 170
• Locations: 4 countries
• Sites: 32

Brief 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.

Conditions

Solid Tumors

Keywords

Advanced or Metastatic Solid Tumors; Melanoma; Non-small Cell Lung Cancer; Nivolumab; DF6002

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose-limiting toxicities (DLTs)

  Dose Escalation

  During the first 3 weeks of treatment

• Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)

  Efficacy Expansion Arms

  Up to 2 years

Secondary Outcomes (21)

• Amount of Treatment Emergent Adverse Events (TEAEs)

  Up to 2 years

• Severity of TEAEs

  Up to 2 years

• Duration of TEAEs

  Up to 2 years

• Number of participants with changes from baseline in clinical laboratory parameters

  Up to 2 years

• Number of participants with changes from baseline in electrocardiogram (ECG) parameters

  Up to 2 years

Study Arms (6)

Dose Escalation / Monotherapy / Subcutaneously or Intravenously

EXPERIMENTAL

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Drug: DF6002

Dose Escalation / Combination / Subcutaneously or Intravenously

EXPERIMENTAL

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Drug: DF6002; Drug: Nivolumab

Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously

EXPERIMENTAL

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Drug: DF6002

Safety/PK/PD / Combination / Subcutaneously or Intravenously

EXPERIMENTAL

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Drug: DF6002; Drug: Nivolumab

Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma

EXPERIMENTAL

Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W

Drug: DF6002; Drug: Nivolumab

Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma

EXPERIMENTAL

Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W

Drug: DF6002; Drug: Nivolumab

Interventions

DF6002 DRUG

Specified dose on specified days

Dose Escalation / Combination / Subcutaneously or Intravenously; Dose Escalation / Monotherapy / Subcutaneously or Intravenously; Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma; Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma; Safety/PK/PD / Combination / Subcutaneously or Intravenously; Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo

Dose Escalation / Combination / Subcutaneously or Intravenously; Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma; Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma; Safety/PK/PD / Combination / Subcutaneously or Intravenously

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dragonfly Therapeutics: lead

Study Sites (32)

University of California Irvine

Orange, California, 92868, United States

Location

SCRI - HealthOne Denver

Denver, Colorado, 80218, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912-0003, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Local Institution

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

SCRI - Tennessee Oncology - Saint Thomas West Clinic

Nashville, Tennessee, 37205, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute and Hospital

Salt Lake City, Utah, 84112, United States

Location

USOR - Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, 22031, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0023

Box Hill, 3128, Australia

Location

Local Institution - 0022

Heidelberg, 3084, Australia

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Dragonfly Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: July 13, 2020
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (21); AU (2); FR (4); ES (5)