Study of DF1001 in Patients With Advanced Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT04143711

Run by

Dragonfly Therapeutics

People needed

270

Starts

2019-11-11

Expected to finish

2025-12-05

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [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 or 5 half-lives before the start of study treatment. Note: Patients receiving bisphosphonates are eligible provided treatment was initiated at least 14 days before the first dose of DF1001.
• Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
• Rapidly progressive disease.
• Active or history of central nervous system (CNS) metastases.
• Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
• Significant acute or chronic infections (including historic positive test for human immunodeficiency virus [HIV], or active or latent hepatitis B or active hepatitis C tested during the screening window).
• Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years or clinically relevant immunodeficiencies (eg, dys-gammaglobulinemia or congenital immunodeficiencies), or fever within 7 days of Day 1.
• Known severe hypersensitivity reactions to mAbs (≥ Grade 3 NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly controlled asthma).
• Persisting toxicity related to prior therapy > Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
• Pregnancy or lactation in females during the study.
• Known alcohol or drug abuse.
• Serious cardiac illness
• NYHA III of IV heart failure or systolic dysfunction (LVEF < 55%)
• High-risk uncontrolled arrhythmias ie, tachycardia with a heart rate > 100/min at rest
• Significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular block (AV-block; second-degree AV-block Type 2 [Mobitz 2] or third-degree AV-block)
• Angina pectoris requiring anti-anginal medication
• Clinically significant valvular heart disease
• Evidence of transmural infarction on ECG
• Poorly controlled hypertension (defined by: systolic > 180 mm Hg or diastolic > 100 mm Hg)
• Clinically relevant uncontrolled cardiac risk factors, clinically relevant pulmonary disease or any clinically relevant medical condition in the opinion of the Investigator that may limit participation in this study.
• Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
• All other significant diseases (e.g., inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's ability to participate
• Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Legal incapacity or limited legal capacity.
• Incapable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol .

Where it is running

• University of California Irvine Medical Center — Irvine, California, United States
• University of Southern California — Los Angeles, California, United States
• Sharp Healthcare — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Kansas Medical Center Research Institute, Inc. — Westwood, Kansas, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center — New York, New York, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Multicare Health System Tacoma General Hospital — Tacoma, Washington, United States
• University of Wisconsin — Madison, Wisconsin, 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
• Rigshospitalet — Copenhagen, Capital Region, Denmark
• Herlev og Gentofte Hospital — Herlev, Denmark
• Institut Curie — Paris, Paris, France
• Groupe Hospitalier Saint Andre — Bordeaux, France
• Centre Oscar Lambret — Lille, France
• Centre Leon Berard — Lyon, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.