Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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).

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

Keywords

Solid Tumor, Adult, EGFR, NK Cell, Immunotherapy, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma, pembrolizumab, KEYTRUDA®, Neoplasms, Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma, Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer, Monotherapy DF9001 Expansion in Renal Cell Carcinoma

Eligibility

Locations

  • UC Irvine Medical Center accepting new patients
    Irvine California 92617 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dragonfly Therapeutics
ID
NCT05597839
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 242 study participants
Last Updated