A Study of DF6002 Alone and in Combination With Nivolumab
- Registration Number
- NCT04423029
- Lead Sponsor
- Dragonfly Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 473
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Dose Expansion (Melanoma) Nivolumab - Combination Dose Expansion (NSCLC) DF6002 - Combination Dose Expansion (Melanoma) DF6002 - Combination Dose Escalation DF6002 - Combination Dose Escalation Nivolumab - Combination Dose Expansion (NSCLC) Nivolumab - Monotherapy Dose Escalation DF6002 - Monotherapy Dose Expansion (Melanoma) DF6002 - Monotherapy Dose Expansion (NSCLC) DF6002 -
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) Up to 2 years Phase 2 only
Number of participants with dose-limiting toxicities (DLTs) During the first 3 weeks of treatment Phase 1/1b only
- Secondary Outcome Measures
Name Time Method Number of participants with changes from baseline in clinical laboratory parameters Up to 2 years Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment Up to 2 years CBR according to RECIST 1.1 per IERC Up to 2 years Phase 2 only
PFS according to RECIST 1.1 per IERC Up to 2 years Phase 2 only
DOR according to RECIST 1.1 per IERC Up to month 24 Phase 2 only
Unconfirmed response after 4 cycles according to RECIST 1.1 Up to 2 years Phase 2 only
Overall Survival (OS) Up to 5 years Phase 2 only
Serum titers of anti-DF6002 antibodies Up to 2 years Phase 2 only
Serum titers of anti-nivolumab antibodies Up to 2 years Phase 2 only
Number of participants with changes from baseline in electrocardiogram (ECG) parameters Up to 2 years Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status Up to 2 years Duration of TEAEs Up to 2 years Number of participants with changes from baseline in vital sign parameters Up to 2 years Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment 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) Up to day 28 Maximum serum concentration observed post-dose (Cmax) Up to day 28 Confirmed ORR per RECIST 1.1 per Investigator assessment Up to 2 years Phase 1/1b only
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment Up to 2 years Phase 2 only
Number of participants with treatment emergent adverse events (TEAEs) Up to 2 years Severity of TEAEs Up to 2 years Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) Up to day 28 Best overall response (BOR) according to RECIST 1.1 per Investigator assessment Approximately one year
Trial Locations
- Locations (33)
USOR - Virginia Cancer Specialists - Fairfax Office
🇺🇸Fairfax, Virginia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
HealthPartners Cancer Center at Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Local Institution
🇪🇸Madrid, Spain
University of California Irvine
🇺🇸Orange, California, United States
Local Institution - 0029
🇪🇸Barcelona, Spain
Local Institution - 0030
🇪🇸Madrid, Spain
Local Institution - 0025
🇪🇸Pamplona, Spain
Local Institution - 0028
🇪🇸Madrid, Spain
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Local Institution - 0023
🇦🇺Box Hill, Australia
Augusta University Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
Local Institution - 0002
🇫🇷Paris, France
Local Institution - 0022
🇦🇺Heidelberg, Australia
Local Institution - 0027
🇫🇷Pierre-Benite, France
Local Institution - 0026
🇫🇷Bordeaux Cedex, France
Local Institution - 0001
🇫🇷Villejuif, France
Local Institution - 0031
🇪🇸Madrid, Spain
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute and Hospital
🇺🇸Salt Lake City, Utah, United States
SCRI - HealthOne Denver
🇺🇸Denver, Colorado, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
SCRI - Tennessee Oncology - Saint Thomas West Clinic
🇺🇸Nashville, Tennessee, United States
Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
University of Miami
🇺🇸Miami, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States