Solid TumorsPhase 1NCT04423029
A Study of DF6002 Alone and in Combination With Nivolumab
A Phase 1 study testing DF6002 and Nivolumab in people with Solid Tumors, run by Dragonfly Therapeutics at 32 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- DF6002 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 13 Jul 2020to 26 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States21 sites
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912-0003
Local Institution
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
SCRI - HealthOne Denver
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Miami
Miami, Florida, 33136
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Atlantic Health System
Morristown, New Jersey, 07960
SCRI - Tennessee Oncology - Saint Thomas West Clinic
Nashville, Tennessee, 37205
Yale School of Medicine
New Haven, Connecticut, 06520
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of California Irvine
Orange, California, 92868
Rhode Island Hospital
Providence, Rhode Island, 02903
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah, 84112
Montefiore Medical Center
The Bronx, New York, 10467
Spain5 sites
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Clinica Universidad de Navarra - Madrid
Madrid, 28027
Hospital Universitario Ramón y Cajal
Madrid, 28034
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
France4 sites
Institut Bergonié
Bordeaux, 33000
Hôpital Saint-Louis
Paris, 75010
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Gustave Roussy
Villejuif, 94805
Australia2 sites
Local Institution - 0023
Box Hill, 3128
Local Institution - 0022
Heidelberg, 3084
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- DF6002, Nivolumab
- Keywords
- Advanced or Metastatic Solid Tumors, Melanoma, Non-small Cell Lung Cancer, Nivolumab, DF6002
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF6002Drug
Specified dose on specified days
NivolumabDrug
Also called Opdivo
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation / Monotherapy / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Receives: Drug: DF6002 |
| Dose Escalation / Combination / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W Receives: Drug: DF6002; Drug: Nivolumab |
| Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Receives: Drug: DF6002 |
| Safety/PK/PD / Combination / Subcutaneously or Intravenously | Experimental | Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W Receives: 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 Receives: 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 Receives: Drug: DF6002; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs)
Dose Escalation
Measured: 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
Measured: Up to 2 years
Secondary outcomes (21)
Amount of Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs
Measured: Up to 2 years
Severity of TEAEs
Severity of the TEAEs seen in study participants
Measured: Up to 2 years
Duration of TEAEs
How long the TEAEs seen last
Measured: Up to 2 years
Number of participants with changes from baseline in clinical laboratory parameters
Overall change, if any, after treatment
Measured: Up to 2 years
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Overall change, if any, after treatment
Measured: Up to 2 years
Number of participants with changes from baseline in vital sign parameters
Overall change, if any, after treatment
Measured: Up to 2 years
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Measured: 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)
Overall change, if any, after treatment
Measured: Up to day 28
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Overall change, if any, after treatment
Measured: Up to day 28
Maximum serum concentration observed post-dose (Cmax)
Overall change, if any, after treatment
Measured: Up to day 28
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Measured: Approximately one year
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Overall change, if any, after treatment
Measured: Up to 2 years
Confirmed ORR per RECIST 1.1 per Investigator assessment
Phase 1/1b only
Measured: Up to 2 years
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Phase 2 only
Measured: Up to 2 years
CBR according to RECIST 1.1 per IERC
Phase 2 only
Measured: Up to 2 years
PFS according to RECIST 1.1 per IERC
Phase 2 only
Measured: Up to 2 years
DOR according to RECIST 1.1 per IERC
Phase 2 only
Measured: Up to month 24
Unconfirmed response after 4 cycles according to RECIST 1.1
Phase 2 only
Measured: Up to 2 years
Overall Survival (OS)
Phase 2 only
Measured: Up to 5 years
Serum titers of anti-DF6002 antibodies
Phase 2 only
Measured: Up to 2 years
Serum titers of anti-nivolumab antibodies
Phase 2 only
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start13 Jul 2020
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonfly Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Dragonfly Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423029
- Sponsor's protocol ID
- DF6002 - 001
- Other IDs
- 2023-510511-19, 2023
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04423029
- Acronym / sponsor ID
- DF6002 - 001
- Conditions
- Solid Tumors
- Keywords
- Advanced or Metastatic Solid Tumors, Melanoma, Non-small Cell Lung Cancer, Nivolumab, DF6002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Dragonfly TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation / Monotherapy / Subcutaneously or Intravenously | Experimental | Drug: DF6002Subcutaneous portion of the study is complete. Dosing DF6002 Q4W |
| Dose Escalation / Combination / Subcutaneously or Intravenously | Experimental | Drug: DF6002, Drug: NivolumabSubcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W |
| Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously | Experimental | Drug: DF6002Subcutaneous portion of the study is complete. Dosing DF6002 Q4W |
| Safety/PK/PD / Combination / Subcutaneously or Intravenously | Experimental | Drug: DF6002, Drug: NivolumabSubcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W |
| Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma | Experimental | Drug: DF6002, Drug: NivolumabSubcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W |
| Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma | Experimental | Drug: DF6002, Drug: NivolumabSubcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF6002Specified dose on specified days | Drug | 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 |
| NivolumabAlso: OpdivoSpecified dose on specified days | Drug | 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 |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs)
Time frame: During the first 3 weeks of treatment
Dose Escalation
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
21 secondary outcomes
Amount of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
Severity of TEAEs
Time frame: Up to 2 years
Duration of TEAEs
Time frame: Up to 2 years
Number of participants with changes from baseline in clinical laboratory parameters
Time frame: Up to 2 years
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Time frame: Up to 2 years
Number of participants with changes from baseline in vital sign parameters
Time frame: Up to 2 years
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Time frame: 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
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Time frame: Up to day 28
Maximum serum concentration observed post-dose (Cmax)
Time frame: Up to day 28
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Time frame: Approximately one year
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Time frame: Up to 2 years
Confirmed ORR per RECIST 1.1 per Investigator assessment
Time frame: Up to 2 years
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Time frame: Up to 2 years
CBR according to RECIST 1.1 per IERC
Time frame: Up to 2 years
PFS according to RECIST 1.1 per IERC
Time frame: Up to 2 years
DOR according to RECIST 1.1 per IERC
Time frame: Up to month 24
Unconfirmed response after 4 cycles according to RECIST 1.1
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 5 years
Serum titers of anti-DF6002 antibodies
Time frame: Up to 2 years
Serum titers of anti-nivolumab antibodies
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Dragonfly Therapeutics
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DF6002 and Nivolumab in people with Solid Tumors, run by Dragonfly Therapeutics at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Spain, France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities (DLTs) (time frame: During the first 3 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.