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Clinical Trial Finder

Search Results

A Study of DF6002 Alone and in Combination With Nivolumab

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
  • - Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04423029
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dragonfly Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Dragonfly Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, France, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors
Additional Details

Assess the safety and tolerability of subcutaneous (SC) and intravenous (IV) administration of DF6002, as monotherapy and in combination with nivolumab, and to determine the maximum tolerated dose (MTD) and recommended efficacy expansion dose (REED) of SC and IV DF6002, both as monotherapy and in combination with nivolumab, for patients with advanced (unresectable, recurrent, or metastatic) solid tumors.

Arms & Interventions

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

Interventions

Drug: - DF6002

Specified dose on specified days

Drug: - Nivolumab

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California Irvine, Orange 5379513, California 5332921

Status

Recruiting

Address

University of California Irvine

Orange 5379513, California 5332921, 92868

Site Contact

Jennifer Valerin, MD

[email protected]

617-588-0086

SCRI - HealthOne Denver, Denver 5419384, Colorado 5417618

Status

Withdrawn

Address

SCRI - HealthOne Denver

Denver 5419384, Colorado 5417618, 80218

Site Contact

[email protected]

617-588-0086

Yale School of Medicine, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale School of Medicine

New Haven 4839366, Connecticut 4831725, 06520

Site Contact

Mario Sznol, MD

[email protected]

617-588-0086

University of Miami, Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami

Miami 4164138, Florida 4155751, 33136

Site Contact

Jose Lutzky, MD

[email protected]

617-588-0086

Augusta University Georgia Cancer Center, Augusta 4180531, Georgia 4197000

Status

Recruiting

Address

Augusta University Georgia Cancer Center

Augusta 4180531, Georgia 4197000, 30912-0003

Site Contact

Sharad Ghamande, MD

[email protected]

617-588-0086

University of Iowa Hospitals and Clinics, Iowa City 4862034, Iowa 4862182

Status

Active, not recruiting

Address

University of Iowa Hospitals and Clinics

Iowa City 4862034, Iowa 4862182, 52242

Site Contact

[email protected]

617-588-0086

Local Institution, Boston 4930956, Massachusetts 6254926

Status

Active, not recruiting

Address

Local Institution

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

[email protected]

617-588-0086

Barbara Ann Karmanos Cancer Institute, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Barbara Ann Karmanos Cancer Institute

Detroit 4990729, Michigan 5001836, 48201

Site Contact

Dipesh Uprety, MD

[email protected]

617-588-0086

Henry Ford Hospital, Detroit 4990729, Michigan 5001836

Status

Active, not recruiting

Address

Henry Ford Hospital

Detroit 4990729, Michigan 5001836, 48202

Site Contact

[email protected]

617-588-0086

Saint Paul 5045360, Minnesota 5037779

Status

Recruiting

Address

HealthPartners Cancer Center at Regions Hospital

Saint Paul 5045360, Minnesota 5037779, 55101

Site Contact

Arkadiusz Dudek, MD

[email protected]

617-588-0086

Atlantic Health System, Morristown 5101427, New Jersey 5101760

Status

Recruiting

Address

Atlantic Health System

Morristown 5101427, New Jersey 5101760, 07960

Site Contact

Eric Whitman

[email protected]

973-971-7111

Roswell Park Comprehensive Cancer Center, Buffalo 5110629, New York 5128638

Status

Withdrawn

Address

Roswell Park Comprehensive Cancer Center

Buffalo 5110629, New York 5128638, 14263

Site Contact

[email protected]

617-588-0086

Montefiore Medical Center, The Bronx 5110266, New York 5128638

Status

Recruiting

Address

Montefiore Medical Center

The Bronx 5110266, New York 5128638, 10467

Site Contact

Jinyu Lu, MD

[email protected]

617-588-0086

Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland 5150529, Ohio 5165418, 44106

Site Contact

Jorge Garcia, MD

[email protected]

617-588-0086

Stephenson Cancer Center, Oklahoma City 4544349, Oklahoma 4544379

Status

Active, not recruiting

Address

Stephenson Cancer Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

[email protected]

617-588-0086

Rhode Island Hospital, Providence 5224151, Rhode Island 5224323

Status

Recruiting

Address

Rhode Island Hospital

Providence 5224151, Rhode Island 5224323, 02903

Site Contact

Benedito Carneiro, MD

[email protected]

617-588-0086

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

SCRI - Tennessee Oncology - Saint Thomas West Clinic

Nashville 4644585, Tennessee 4662168, 37205

Site Contact

Meredith McKean, MD

[email protected]

617-588-0086

Houston 4699066, Texas 4736286

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Hussein Tawbi, MD

[email protected]

617-588-0086

Houston 4699066, Texas 4736286

Status

Active, not recruiting

Address

University of Texas MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

[email protected]

617-588-0086

Huntsman Cancer Institute and Hospital, Salt Lake City 5780993, Utah 5549030

Status

Recruiting

Address

Huntsman Cancer Institute and Hospital

Salt Lake City 5780993, Utah 5549030, 84112

Site Contact

Siwen Hu-Lieskovan, MD

[email protected]

617-588-0086

Fairfax 4758023, Virginia 6254928

Status

Recruiting

Address

USOR - Virginia Cancer Specialists - Fairfax Office

Fairfax 4758023, Virginia 6254928, 22031

Site Contact

Alexander Spira, Site 0015

[email protected]

703-280-5390

Froedtert Hospital, Milwaukee 5263045, Wisconsin 5279468

Status

Active, not recruiting

Address

Froedtert Hospital

Milwaukee 5263045, Wisconsin 5279468, 53226

Site Contact

[email protected]

617-588-0086

International Sites

Local Institution - 0023, Box Hill 2174360, Australia

Status

Withdrawn

Address

Local Institution - 0023

Box Hill 2174360, , 3128

Site Contact

[email protected]

617-588-0086

Local Institution - 0022, Heidelberg 2163654, Australia

Status

Withdrawn

Address

Local Institution - 0022

Heidelberg 2163654, , 3084

Site Contact

[email protected]

617-588-0086

Institut Bergonié, Bordeaux 3031582, France

Status

Recruiting

Address

Institut Bergonié

Bordeaux 3031582, , 33000

Site Contact

[email protected]

617-588-0086

Hôpital Saint-Louis, Paris 2988507, France

Status

Recruiting

Address

Hôpital Saint-Louis

Paris 2988507, , 75010

Site Contact

[email protected]

617-588-0086

Centre Hospitalier Lyon-Sud, Pierre-Bénite 2987314, France

Status

Recruiting

Address

Centre Hospitalier Lyon-Sud

Pierre-Bénite 2987314, , 69495

Site Contact

[email protected]

617-588-0086

Gustave Roussy, Villejuif 2968705, France

Status

Recruiting

Address

Gustave Roussy

Villejuif 2968705, , 94805

Site Contact

[email protected]

617-588-0086

Hospital Universitari Vall d'Hebrón, Barcelona 3128760, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebrón

Barcelona 3128760, , 08035

Site Contact

[email protected]

617-588-0086

Clinica Universidad de Navarra - Madrid, Madrid 3117735, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra - Madrid

Madrid 3117735, , 28027

Site Contact

[email protected]

617-588-0086

Hospital Universitario Ramón y Cajal, Madrid 3117735, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal

Madrid 3117735, , 28034

Site Contact

[email protected]

617-588-0086

Madrid 3117735, Spain

Status

Recruiting

Address

START Madrid - Hospital Universitario Fundación Jiménez Díaz

Madrid 3117735, , 28040

Site Contact

[email protected]

617-588-0086

Pamplona 3114472, Spain

Status

Recruiting

Address

Clinica Universidad de Navarra - Pamplona

Pamplona 3114472, , 31008

Site Contact

[email protected]

617-588-0086

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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