Study of DF9001 in Patients With Advanced Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult

In brief

DF9001-001 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 epidermal growth factor receptor (EGFR). 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 selected solid tumors (monotherapy and in combination with pembrolizumab).

Key facts

Study ID: NCT05597839
Run by: Dragonfly Therapeutics
People needed: 24
Starts: 2022-11-15
Expected to finish: 2025-08-15
Last updated by the study team: 2025-10-29

Who can join

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

You may not qualify if…

Patients must not have had chemotherapy, radiotherapy (other than palliative bone- directed radiotherapy, as described in in exclusion criterion #2), or major surgery, or received another investigational agent within 28 days or 5 half-lives of the drug (if known), whichever is shorter, before the start of study treatment.
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
a. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for palliative bone-directed radiotherapy, which is not a target lesion], 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 of the drug (if known), whichever is shorter, before the start of study treatment. Short-term administration of systemic steroids (eg, for allergic reactions or the management of irAEs) is allowed. Note: Patients receiving bisphosphonate or denosumab are eligible, provided treatment was initiated at least 14 days before the first dose of DF9001.
Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years. Exceptions (eg, basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ) can be considered on a case-by-case basis, in consultation with the Medical Monitor.
Life expectancy of less than 6 months.
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). If HBsAg is negative and the anti-hepatitis B core antibody is positive, then hepatitis B viral DNA load must be undetectable.
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, dysgammaglobulinemia or congenital immunodeficiencies). Patients with a history of immune-related endocrinopathies (eg, hypothyroidism, type 1 diabetes mellitus [TIDM], and adrenal insufficiency) that are stable on hormone replacement therapy may be eligible for this study.
Patients with a known medical history that may place them at risk of known toxicities of EGFR blockade.
History of or ongoing keratitis, ulcerative keratitis, or corneal perforation.
History of cardiopulmonary arrest unless this was caused by an acute, reversible etiology that is no longer present.
History of or ongoing pulmonary fibrosis or interstitial lung disease.
Known severe hypersensitivity reactions to mAbs (≥ Grade 3 of the 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 ≤Grade 2, endocrinopathies ≤Grade 2, and sensory neuropathy ≤ Grade 2 is acceptable.
Patients who have received an anti-PD-(L)1 as a previous line of therapy that have experienced either of the following:
a Grade 3 or Grade 4 drug-related toxicity.
a Grade 2 drug-related toxicity that impacted either the lungs, cardiac, or the nervous system, caused by the administration of the anti-PD-(L)1.
Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed.
Pregnancy or lactation in females during the study.
Known alcohol or drug abuse.
Serious cardiac illness or medical conditions, including but not limited to:

Where it is running

Banner MD Anderson — Gilbert, Arizona, United States
Mayo Clinic Arizona — Phoenix, Arizona, United States
UC Irvine Medical Center — Irvine, California, United States
USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
University of Louisville Hospital — Louisville, Kentucky, United States
Mayo Clinic Minnesota — Rochester, Minnesota, United States
AMR Kansas City — Kansas City, Missouri, United States
Rutgers — New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
UMPC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Virginia Cancer Specialists — Fairfax, Virginia, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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