Study of DF9001 in Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT05597839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/1b First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF9001 as a Monotherapy and in Combination Therapies in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05597839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2022
- Primary completion
- Aug 14, 2025
- Completion
- Aug 14, 2025
- Last update posted
- Oct 28, 2025
2022 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| UC Irvine Medical Center | Irvine | California | 92617 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | — |
| AMR Kansas City | Kansas City | Missouri | 64114 | — |
| Rutgers | New Brunswick | New Jersey | 08903 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| UMPC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05597839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05597839 live on ClinicalTrials.gov.