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NCT04423029 Clinical Trial

A Study of DF6002 Alone and in Combination With Nivolumab

Solid Tumors Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04423029
Other study ID # CA101-001
Secondary ID 2021-000038-33
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 13, 2020
Est. completion date December 16, 2025

Study information
Verified date April 2023
Source Dragonfly Therapeutics
Contact Sean Rossi
Phone 617-588-0086
Email sean.rossi@dragonflytx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 473
Est. completion date December 16, 2025
Est. primary completion date July 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• DF6002
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations
Country Name City State
Australia Local Institution - 0023 Box Hill
Australia Local Institution - 0022 Heidelberg
France Local Institution - 0026 Bordeaux Cedex
France Local Institution Paris Ile-de-France
France Local Institution - 0002 Paris
France Local Institution - 0027 Pierre-Benite
France Local Institution Pierre-Bénite Rhone
France Local Institution - 0001 Villejuif
Spain Local Institution - 0029 Barcelona
Spain Local Institution Madrid
Spain Local Institution Madrid
Spain Local Institution - 0028 Madrid
Spain Local Institution - 0030 Madrid
Spain Local Institution - 0031 Madrid
Spain Local Institution Pamplona Navarre
Spain Local Institution - 0025 Pamplona
United States Augusta University Georgia Cancer Center Augusta Georgia
United States Local Institution Augusta Georgia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Local Institution Boston Massachusetts
United States Local Institution Bronx New York
United States Montefiore Medical Center Bronx New York
United States Local Institution Buffalo New York
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Local Institution Cleveland Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States SCRI - HealthOne Denver Denver Colorado
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Local Institution Detroit Michigan
United States Local Institution Fairfax Virginia
United States USOR - Virginia Cancer Specialists - Fairfax Office Fairfax Virginia
United States Local Institution Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Local Institution Miami Florida
United States University of Miami Miami Florida
United States Froedtert Hospital Milwaukee Wisconsin
United States Atlantic Health System Morristown New Jersey
United States Local Institution Nashville Tennessee
United States SCRI - Tennessee Oncology - Saint Thomas West Clinic Nashville Tennessee
United States Local Institution New Haven Connecticut
United States Yale School of Medicine New Haven Connecticut
United States Local Institution Oklahoma City Oklahoma
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Local Institution Orange California
United States University of California Irvine Orange California
United States Local Institution Providence Rhode Island
United States Rhode Island Hospital Providence Rhode Island
United States HealthPartners Cancer Center at Regions Hospital Saint Paul Minnesota
United States Local Institution Saint Paul Minnesota
United States Huntsman Cancer Institute and Hospital Salt Lake City Utah
United States Local Institution Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Dragonfly Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  France,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with dose-limiting toxicities (DLTs) Phase 1/1b only During the first 3 weeks of treatment
Primary Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) Phase 2 only Up to 2 years
Secondary Number of participants with treatment emergent adverse events (TEAEs) Up to 2 years
Secondary Severity of TEAEs Up to 2 years
Secondary Duration of TEAEs Up to 2 years
Secondary Number of participants with changes from baseline in clinical laboratory parameters Up to 2 years
Secondary Number of participants with changes from baseline in electrocardiogram (ECG) parameters Up to 2 years
Secondary Number of participants with changes from baseline in vital sign parameters Up to 2 years
Secondary Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status Up to 2 years
Secondary Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment Up to month 24
Secondary 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
Secondary Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) Up to day 28
Secondary Maximum serum concentration observed post-dose (Cmax) Up to day 28
Secondary Best overall response (BOR) according to RECIST 1.1 per Investigator assessment Approximately one year
Secondary Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment Up to 2 years
Secondary Confirmed ORR per RECIST 1.1 per Investigator assessment Phase 1/1b only Up to 2 years
Secondary Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment Phase 2 only Up to 2 years
Secondary CBR according to RECIST 1.1 per IERC Phase 2 only Up to 2 years
Secondary PFS according to RECIST 1.1 per IERC Phase 2 only Up to 2 years
Secondary DOR according to RECIST 1.1 per IERC Phase 2 only Up to month 24
Secondary Unconfirmed response after 4 cycles according to RECIST 1.1 Phase 2 only Up to 2 years
Secondary Overall Survival (OS) Phase 2 only Up to 5 years
Secondary Serum titers of anti-DF6002 antibodies Phase 2 only Up to 2 years
Secondary Serum titers of anti-nivolumab antibodies Phase 2 only Up to 2 years
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