RecruitingPhase 1Phase 2NCT04143711

Study of DF1001 in Patients with Advanced Solid Tumors

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Sponsor

Dragonfly Therapeutics

Enrollment

378 participants

Start Date

Nov 11, 2019

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult

Summary

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called DF1001, alone or in combination with other cancer drugs, for people with advanced solid tumors that express a protein called HER2. It includes multiple groups for different cancer types such as non-small cell lung cancer, breast cancer, gastric cancer, esophageal cancer, and bladder cancer. **You may be eligible if...** - You are 18 or older with good overall health (ECOG 0-1) and a life expectancy of at least 3 months - You have advanced (unresectable or metastatic) solid tumor cancer that expresses HER2 (confirmed by biopsy) - Depending on the study group, you may need to have a specific cancer type (breast, lung, gastric, esophageal, or bladder) and have progressed on standard treatments - Your heart function (LVEF ≥ 55%) and blood counts are within acceptable levels **You may NOT be eligible if...** - You have active or prior central nervous system (brain) metastases - You have HIV, active hepatitis B or C - You have a known severe autoimmune disease requiring ongoing treatment - You are pregnant or breastfeeding - You have had a recent organ transplant - You have serious heart problems (heart failure, significant arrhythmia, or recent heart attack) - You have rapidly progressing disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDF1001

Immunotherapy agent targeting NK cells.

DRUGNivolumab

Anti-PD-1 immunotherapy agent

DRUGNab paclitaxel

A chemotherapy treatment combining paclitaxel with albumin

DRUGSacituzumab Govitecan-hziy

A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate

Locations(52)

Louisiana State University

New Orleans, Louisiana, United States

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

University of Wisconsin

Madison, Wisconsin, United States

University of California Irvine Medical Center

Irvine, California, United States

Asan Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center

New York, New York, United States

University of Kansas Medical Center Research Institute, Inc.

Westwood, Kansas, United States

Amsterdam University Medical Center

Amsterdam, Netherlands

Montefiore Einstein Center for Cancer Care

The Bronx, New York, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Multicare Health System Tacoma General Hospital

Tacoma, Washington, United States

Centre Hospitalier de l'Ardenne

Arlon, Belgium

Grand Hopital de Charleroi

Charleroi, Belgium

Domaine Universitaire du Sart Tilman; CHU de Liege

Liège, Belgium

Herlev og Gentofte Hospital

Herlev, Denmark

Groupe Hospitalier Saint Andre

Bordeaux, France

Centre Georges-Francois Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Institut Regional du Cancer de Montepelier

Montpellier, France

CHU de Rennes Hopital Pontechaillou

Rennes, France

ICO - Site Rene Gauducheau

Saint-Herblain, France

Institut Claudius Regaud

Toulouse, France

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Maasticht University Medical Center

Maastricht, Netherlands

Radboud University Nijmegen

Nijmegen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

National Cancer Center

Goyang-si, South Korea

Ajou University Hospital

Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

University of Michigan

Ann Arbor, Michigan, United States

Institut Paoli Calmettes

Marseille, France

Institut Curie

Paris, Paris, France

Rhode Island Hospital

Providence, Rhode Island, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Sharp Healthcare

San Diego, California, United States

Rigshospitalet

Copenhagen, Capital Region, Denmark

The Ohio State University

Columbus, Ohio, United States

Centre Leon Berard

Lyon, France

University of Southern California

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Kosin University Gospel Hospital

Busan, South Korea

Groupe Hospitalier Pitie Salpetriere

Paris, France

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