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A Study of DF6002 Alone and in Combination With Nivolumab | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of DF6002 Alone and in Combination With Nivolumab

A Phase 1/1b, 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

NCT04423029•Dragonfly Therapeutics

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (32)

University of California Irvine

Orange, California, United States

SCRI - HealthOne Denver

Denver, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Augusta University Georgia Cancer Center

Augusta, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Local Institution

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Key Dates

Start Date

July 13, 2020

Primary Completion Date

November 26, 2025

Completion Date

November 26, 2025

Last Updated

March 18, 2026

Enrollment

170

ACTUAL participants

Conditions

Solid Tumors

Interventions

DF6002

DRUG

Nivolumab

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of DF6002 Alone and in Combination With Nivolumab

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors