Study of DF1001 in Patients With Advanced Solid Tumors (NCT04143711) | Clinical Trial Compass
CompletedPhase 1/2
Study of DF1001 in Patients With Advanced Solid Tumors
United States270 participantsStarted 2019-11-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent.
✓. Male or female patients aged ≥ 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
✓. Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 55% measured by echocardiography (preferred) or multigated acquisition (MUGA) scan.
✓. Adequate hematological function.
✓. Adequate hepatic function.
✓. Adequate renal function.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Timeframe: First 3 weeks of treatment for each subject.
2
Assess Overall Response Rate
Timeframe: Through 90 days after completion of the study, an average of 1 year.
3
Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab
Timeframe: Screening visit up to 28 days after last treatment on study.
4
Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel
Timeframe: Screening visit up to 28 days after last treatment on study.
5
Assess number of adverse events observed during treatment with DF1001 in combination with Sacituzumab govitecan-hziy
Timeframe: Screening visit up to 28 days after last treatment on study.
✕. 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).