RECRUITING

A Study of DF6002 Alone and in Combination With Nivolumab

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-07-13
Study Completion:2025-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04423029

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * ECOG performance status of 0 or 1
  3. * Clinical or radiological evidence of disease
  4. * Adequate hematological, hepatic and renal function
  5. * 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
  1. * 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
  2. * 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
  3. * Rapidly progressive disease
  4. * Serious cardiac illness or medical conditions
  5. * Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Contacts and Locations

Study Contact

Sean Rossi
CONTACT
617-588-0086
sean.rossi@dragonflytx.com

Principal Investigator

Jean-Marie Cuillerot, MD
STUDY_DIRECTOR
Chief Medical Officer

Study Locations (Sites)

Local Institution
Orange, California, 92868
United States
University of California Irvine
Orange, California, 92868
United States
SCRI - HealthOne Denver
Denver, Colorado, 80218
United States
Local Institution
New Haven, Connecticut, 06520
United States
Yale School of Medicine
New Haven, Connecticut, 06520
United States
Local Institution
Miami, Florida, 33136
United States
University of Miami
Miami, Florida, 33136
United States
Augusta University Georgia Cancer Center
Augusta, Georgia, 30912-0003
United States
Local Institution
Augusta, Georgia, 30912
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Local Institution
Boston, Massachusetts, 02215
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Local Institution
Detroit, Michigan, 48202
United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, 55101
United States
Local Institution
Saint Paul, Minnesota, 55101
United States
Atlantic Health System
Morristown, New Jersey, 07960
United States
Local Institution
Bronx, New York, 10461
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Local Institution
Buffalo, New York, 14203
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Local Institution
Cleveland, Ohio, 44106
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Local Institution
Oklahoma City, Oklahoma, 73104
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Local Institution
Providence, Rhode Island, 02903
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Local Institution
Nashville, Tennessee, 37205
United States
SCRI - Tennessee Oncology - Saint Thomas West Clinic
Nashville, Tennessee, 37205
United States
Local Institution
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Institute and Hospital
Salt Lake City, Utah, 84112
United States
Local Institution
Salt Lake City, Utah, 84112
United States
Local Institution
Fairfax, Virginia, 22031
United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Dragonfly Therapeutics

  • Jean-Marie Cuillerot, MD, STUDY_DIRECTOR, Chief Medical Officer

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 Registration Dates

Study Start Date2020-07-13
Study Completion Date2025-12-16

Study Record Updates

Study Start Date2020-07-13
Study Completion Date2025-12-16

Terms related to this study

Keywords Provided by Researchers

  • Advanced or Metastatic Solid Tumors
  • Melanoma
  • Non-small Cell Lung Cancer
  • Nivolumab
  • DF6002 (BMS-986415)

Additional Relevant MeSH Terms

  • Solid Tumors