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Evaluating DF6002 with and without Nivolumab for advanced solid tumors

A Phase 1/1b, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

PHASE1 · Dragonfly Therapeutics · NCT04423029

This study is testing a new treatment called DF6002, both by itself and with another drug called Nivolumab, to see how safe it is and how well it works for people with advanced solid tumors.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment438 (estimated)
Ages18 Years and up
SexAll
SponsorDragonfly Therapeutics (industry)
Drugs / interventionsNivolumab
Locations33 sites (Orange, California and 32 other locations)
Trial IDNCT04423029 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of DF6002, both alone and in combination with Nivolumab, in patients with advanced solid tumors. It will evaluate drug levels, effects, and preliminary anti-tumor activity through subcutaneous and intravenous administration. The study will also determine the maximum tolerated dose and recommended efficacy expansion dose for these treatments in participants with unresectable, recurrent, or metastatic solid tumors.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors, such as melanoma or non-small cell lung cancer, who have not responded to standard therapies.

Not a fit: Patients currently receiving other anticancer treatments or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Orange, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumors, Advanced or Metastatic Solid Tumors, Melanoma, Non-small Cell Lung Cancer, Nivolumab, DF6002

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.