A Study of DF6002 Alone and in Combination With Nivolumab

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.

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

A Study of DF6002 Alone and in Combination With Nivolumab

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Orange

Local Institution, Orange, California, United States, 92868

Orange

University of California Irvine, Orange, California, United States, 92868

Denver

SCRI - HealthOne Denver, Denver, Colorado, United States, 80218

New Haven

Local Institution, New Haven, Connecticut, United States, 06520

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06520

Miami

Local Institution, Miami, Florida, United States, 33136

Miami

University of Miami, Miami, Florida, United States, 33136

Augusta

Augusta University Georgia Cancer Center, Augusta, Georgia, United States, 30912-0003

Augusta

Local Institution, Augusta, Georgia, United States, 30912

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dragonfly Therapeutics,

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

Study Record Dates

2025-12-16