CompletedPhase 1NCT04423029

A Study of DF6002 Alone and in Combination With Nivolumab

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.

Checked against the public recordLast updated Mar 18, 2026 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations32
SponsorDragonfly Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Dragonfly Therapeutics
Interventions being studied
Drug: DF6002; Drug: Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California IrvineOrange, California
  • SCRI - HealthOne DenverDenver, Colorado
  • Yale School of MedicineNew Haven, Connecticut
  • University of MiamiMiami, Florida
  • Augusta University Georgia Cancer CenterAugusta, Georgia
  • University of Iowa Hospitals and ClinicsIowa City, Iowa
  • Local InstitutionBoston, Massachusetts
  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • Henry Ford HospitalDetroit, Michigan
  • HealthPartners Cancer Center at Regions HospitalSaint Paul, Minnesota
  • Atlantic Health SystemMorristown, New Jersey
  • Roswell Park Comprehensive Cancer CenterBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2026. Always confirm current availability with the study team.

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