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Study of DF1001 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT04143711•Dragonfly Therapeutics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent.
•2. Male or female patients aged ≥ 18 years.
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
•4. Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
•5. Adequate hematological function.
•6. Adequate hepatic function.
•7. Adequate renal function.
•8. Effective contraception for women of child bearing potential (WOCBP) patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.
•1. Have progression of unresectable locally advanced or metastatic NSCLC after last systemic therapy (as confirmed by investigator) or be intolerant of last systemic therapy.
•2. Have HER2 overexpression status (IHC 2+ or 3+), or ERBB2 amplification, or HER2 activating mutation
+50 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. Rapidly progressive disease.
•4. Active or history of central nervous system (CNS) metastases.
•5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
•6. 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).
•7. 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.
•8. 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).
•9. Persisting toxicity related to prior therapy \> Grade 1 NCI-CTCAE v5.0, however alopecia and sensory neuropathy ≤ Grade 2 is acceptable.
•10. Pregnancy or lactation in females during the study.
+15 more criteria

Locations (44)

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

Key Dates

Start Date

November 11, 2019

Primary Completion Date

December 5, 2025

Completion Date

December 5, 2025

Last Updated

March 18, 2026

Enrollment

270

ACTUAL participants

Conditions

Solid Tumor, Adult

Interventions

DF1001

DRUG

Nivolumab

DRUG

Nab paclitaxel

DRUG

Sacituzumab Govitecan-hziy

DRUG

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

NCT05223608

Solid Tumor, Adult

View study

RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

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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Study of DF1001 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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