- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423029
A Study of DF6002 Alone and in Combination With Nivolumab
April 19, 2023 updated by: Dragonfly Therapeutics
A Phase 1/2, 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
Study Type
Interventional
Enrollment (Anticipated)
473
Phase
- Phase 2
- 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
- Name: Sean Rossi
- Phone Number: 617-588-0086
- Email: sean.rossi@dragonflytx.com
Study Locations
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-
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Box Hill, Australia, 3128
- Withdrawn
- Local Institution - 0023
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Heidelberg, Australia, 3084
- Withdrawn
- Local Institution - 0022
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-
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Bordeaux Cedex, France, 33000
- Recruiting
- Local Institution - 0026
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Paris, France, 75010
- Recruiting
- Local Institution - 0002
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Pierre-Benite, France, 69495
- Recruiting
- Local Institution - 0027
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Villejuif, France, 94805
- Recruiting
- Local Institution - 0001
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Ile-de-France
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Paris, Ile-de-France, France, 75010
- Recruiting
- Local Institution
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Rhone
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Pierre-Bénite, Rhone, France, 69495
- Recruiting
- Local Institution
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-
-
-
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Barcelona, Spain, 08035
- Recruiting
- Local Institution - 0029
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Madrid, Spain, 28034
- Recruiting
- Local Institution
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Madrid, Spain, 08040
- Recruiting
- Local Institution
-
Madrid, Spain, 28027
- Recruiting
- Local Institution - 0031
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Madrid, Spain, 28034
- Recruiting
- Local Institution - 0030
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Madrid, Spain, 28040
- Recruiting
- Local Institution - 0028
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Pamplona, Spain, 31008
- Recruiting
- Local Institution - 0025
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Navarre
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Pamplona, Navarre, Spain, 31008
- Recruiting
- Local Institution
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-
-
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California
-
Orange, California, United States, 92868
- Recruiting
- University of California Irvine
-
Contact:
- Jennifer Valerin, MD
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Orange, California, United States, 92868
- Recruiting
- Local Institution
-
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Colorado
-
Denver, Colorado, United States, 80218
- Withdrawn
- SCRI - HealthOne Denver
-
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Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Yale School of Medicine
-
Contact:
- Mario Sznol, MD
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New Haven, Connecticut, United States, 06520
- Recruiting
- Local Institution
-
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami
-
Contact:
- Jose Lutzky, MD
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Miami, Florida, United States, 33136
- Recruiting
- Local Institution
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Georgia
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Augusta, Georgia, United States, 30912-0003
- Recruiting
- Augusta University Georgia Cancer Center
-
Contact:
- Sharad Ghamande, MD
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Augusta, Georgia, United States, 30912
- Recruiting
- Local Institution
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa Hospitals and Clinics
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Contact:
- Mohammed Milhem, MD
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
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Contact:
- Elizabeth Buchbinder, MD
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Boston, Massachusetts, United States, 02215
- Recruiting
- Local Institution
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Michigan
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Detroit, Michigan, United States, 48201
- Recruiting
- Barbara Ann Karmanos Cancer Institute
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Contact:
- Dipesh Uprety, MD
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
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Contact:
- Raghad Abdul-Karim, MD
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Detroit, Michigan, United States, 48202
- Recruiting
- Local Institution
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Minnesota
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Saint Paul, Minnesota, United States, 55101
- Recruiting
- HealthPartners Cancer Center at Regions Hospital
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Contact:
- Arkadiusz Dudek, MD
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Saint Paul, Minnesota, United States, 55101
- Recruiting
- Local Institution
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New Jersey
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Morristown, New Jersey, United States, 07960
- Recruiting
- Atlantic Health System
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New York
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Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center
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Contact:
- Jinyu Lu, MD
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Bronx, New York, United States, 10461
- Recruiting
- Local Institution
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Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Comprehensive Cancer Center
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Buffalo, New York, United States, 14203
- Recruiting
- Local Institution
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Ohio
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Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center
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Contact:
- Jorge Garcia, MD
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Cleveland, Ohio, United States, 44106
- Recruiting
- Local Institution
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Stephenson Cancer Center
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Contact:
- Raid Aljumaily, MD
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Local Institution
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
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Contact:
- Benedito Carneiro, MD
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Providence, Rhode Island, United States, 02903
- Recruiting
- Local Institution
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Tennessee
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Nashville, Tennessee, United States, 37205
- Recruiting
- Local Institution
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Nashville, Tennessee, United States, 37205
- Recruiting
- SCRI - Tennessee Oncology - Saint Thomas West Clinic
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
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Houston, Texas, United States, 77030
- Recruiting
- Local Institution
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Utah
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Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute and Hospital
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Contact:
- Siwen Hu-Lieskovan, MD
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Salt Lake City, Utah, United States, 84112
- Recruiting
- Local Institution
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- Local Institution
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Fairfax, Virginia, United States, 22031
- Recruiting
- USOR - Virginia Cancer Specialists - Fairfax Office
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert Hospital
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Contact:
- Ariel Nelson, MD
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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
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
- 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 |
Intervention / Treatment |
---|---|
Experimental: Monotherapy Dose Escalation
|
Specified dose on specified days
Other Names:
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Experimental: Monotherapy Dose Expansion (Melanoma)
|
Specified dose on specified days
Other Names:
|
Experimental: Monotherapy Dose Expansion (NSCLC)
|
Specified dose on specified days
Other Names:
|
Experimental: Combination Dose Escalation
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
Experimental: Combination Dose Expansion (Melanoma)
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
Experimental: Combination Dose Expansion (NSCLC)
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: During the first 3 weeks of treatment
|
Phase 1/1b only
|
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
|
Phase 2 only
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: Up to 2 years
|
Up to 2 years
|
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Severity of TEAEs
Time Frame: Up to 2 years
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Up to 2 years
|
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Duration of TEAEs
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of participants with changes from baseline in clinical laboratory parameters
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of participants with changes from baseline in vital sign parameters
Time Frame: Up to 2 years
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Up to 2 years
|
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Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame: Up to 2 years
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Up to 2 years
|
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Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to month 24
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Up to month 24
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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
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Up to day 28
|
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Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Time Frame: Up to day 28
|
Up to day 28
|
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Maximum serum concentration observed post-dose (Cmax)
Time Frame: Up to day 28
|
Up to day 28
|
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Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Approximately one year
|
Approximately one year
|
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Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
|
Up to 2 years
|
|
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
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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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jean-Marie Cuillerot, MD, Chief Medical Officer
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.
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)
July 13, 2020
Primary Completion (Anticipated)
July 19, 2024
Study Completion (Anticipated)
December 16, 2025
Study Registration Dates
First Submitted
June 5, 2020
First Submitted That Met QC Criteria
June 5, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA101-001
- 2021-000038-33 (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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