A Study of DF6002 Alone and in Combination With Nivolumab

Part of paid clinical trials in Orange, California.

Sponsor
Dragonfly Therapeutics
Study ID
NCT04423029
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DF6002 — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jul 13, 2020
Status verified
Mar 2026
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025

Study Design

Enrollment
170 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation / Monotherapy / Subcutaneously or Intravenously
    Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
  • Experimental: Dose Escalation / Combination / Subcutaneously or Intravenously
    Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
  • Experimental: Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously
    Subcutaneous portion of the study is complete. Dosing DF6002 Q4W
  • Experimental: Safety/PK/PD / Combination / Subcutaneously or Intravenously
    Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W
  • Experimental: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma
    Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W
  • Experimental: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma
    Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: During the first 3 weeks of treatment ]

Locations (21)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
SCRI - HealthOne DenverDenverColorado80218-
Yale School of MedicineNew HavenConnecticut06520-
University of MiamiMiamiFlorida33136-
Augusta University Georgia Cancer CenterAugustaGeorgia30912-0003-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Local InstitutionBostonMassachusetts02215-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Henry Ford HospitalDetroitMichigan48202-
HealthPartners Cancer Center at Regions HospitalSaint PaulMinnesota55101-
Atlantic Health SystemMorristownNew Jersey07960-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Montefiore Medical CenterThe BronxNew York10467-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Rhode Island HospitalProvidenceRhode Island02903-
SCRI - Tennessee Oncology - Saint Thomas West ClinicNashvilleTennessee37205-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute and HospitalSalt Lake CityUtah84112-
USOR - Virginia Cancer Specialists - Fairfax OfficeFairfaxVirginia22031-
Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Orange, CA

By research site
University of California Irvine· Orange, CASCRI - HealthOne Denver· Denver, COYale School of Medicine· New Haven, CTUniversity of Miami· Miami, FLAugusta University Georgia Cancer Center· Augusta, GAUniversity of Iowa Hospitals and Clinics· Iowa City, IA

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