A Study of DF6002 Alone and in Combination With Nivolumab

March 16, 2026 updated by: Dragonfly Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Box Hill, Australia, 3128
        • Local Institution - 0023
      • Heidelberg, Australia, 3084
        • Local Institution - 0022
  • France
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon-Sud
      • Villejuif, France, 94805
        • Gustave Roussy
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra - Madrid
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • START Madrid - Hospital Universitario Fundacion Jimenez Diaz
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra - Pamplona
  • United States
    • California
      • Orange, California, United States, 92868
        • University of California Irvine
    • Colorado
      • Denver, Colorado, United States, 80218
        • SCRI - HealthOne Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Augusta, Georgia, United States, 30912-0003
        • Augusta University Georgia Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • HealthPartners Cancer Center at regions Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Comprehensive Cancer Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • SCRI - Tennessee Oncology - Saint Thomas West Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute and Hospital
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • USOR - Virginia Cancer Specialists - Fairfax Office
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation / Monotherapy / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Dose Escalation / Combination / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Safety/PK/PD / Combination / Subcutaneously or Intravenously
Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma
Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: 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
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: DF6002
Specified dose on specified days
Other Names:
  • BMS-986415

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: During the first 3 weeks of treatment
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)
Time Frame: Up to 2 years
Efficacy Expansion Arms
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Confirmed ORR per RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Phase 1/1b only
Up to 2 years
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
CBR according to RECIST 1.1 per IERC
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
PFS according to RECIST 1.1 per IERC
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
DOR according to RECIST 1.1 per IERC
Time Frame: Up to month 24
Phase 2 only
Up to month 24
Unconfirmed response after 4 cycles according to RECIST 1.1
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
Overall Survival (OS)
Time Frame: Up to 5 years
Phase 2 only
Up to 5 years
Serum titers of anti-DF6002 antibodies
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
Serum titers of anti-nivolumab antibodies
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
Amount of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years
Number of participants with TEAEs
Up to 2 years
Severity of TEAEs
Time Frame: Up to 2 years
Severity of the TEAEs seen in study participants
Up to 2 years
Duration of TEAEs
Time Frame: Up to 2 years
How long the TEAEs seen last
Up to 2 years
Number of participants with changes from baseline in clinical laboratory parameters
Time Frame: Up to 2 years
Overall change, if any, after treatment
Up to 2 years
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Time Frame: Up to 2 years
Overall change, if any, after treatment
Up to 2 years
Number of participants with changes from baseline in vital sign parameters
Time Frame: Up to 2 years
Overall change, if any, after treatment
Up to 2 years
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to month 24
Overall change, if any, after treatment
Up to month 24
Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)
Time Frame: Up to day 28
Overall change, if any, after treatment
Up to day 28
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Time Frame: Up to day 28
Overall change, if any, after treatment
Up to day 28
Maximum serum concentration observed post-dose (Cmax)
Time Frame: Up to day 28
Overall change, if any, after treatment
Up to day 28
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Approximately one year
Overall change, if any, after treatment
Approximately one year
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Overall change, if any, after treatment
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dragonfly Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Clinical Trials, Dragonfly Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DF6002 - 001
  • 2023-510511-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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