Clinical trial NCT05597839: Study of DF9001 in Patients With Advanced Solid Tumors
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
Conditions: Solid Tumor, Adult
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).
Interventions:
description: Immunotherapy agent targeting NK cells.
name: DF9001
type: Drug
description: Anti-PD-1 immunotherapy agent
name: KEYTRUDA® (pembrolizumab)
type: Drug
Study arms:
design_group_description: Dose escalation cohorts of DF9001 in sequential ascending order.
design_group_title: Monotherapy DF9001 Dose Escalation
design_group_type: Experimental
design_group_description: Monotherapy expansion cohort enrolling up to 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
design_group_title: Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma
design_group_type: Experimental
design_group_description: Monotherapy expansion cohort enrolling up to 20-40 patients with Non-small cell lung cancer (NSCLC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
design_group_title: Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
design_group_type: Experimental
design_group_description: Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with head and neck squamous cell carcinoma (HNSCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
design_group_title: Combination Expansion of DF9001 and pembrolizumab in Head and Neck Squamous Cell Carcinoma
design_group_type: Experimental
design_group_description: Combination expansion cohort using DF9001 and a PD-1 checkpoint inhibitor enrolling 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
design_group_title: Combination Expansion of DF9001 and pembrolizumab in Renal Cell Carcinoma
design_group_type: Experimental
design_group_description: Monotherapy expansion cohort enrolling up to 20-40 patients with renal cell carcinoma (RCC) using the recommended phase 1b dose (REED) identified in the Monotherapy Dose Escalation arm.
design_group_title: Monotherapy DF9001 Expansion in Renal Cell Carcinoma
design_group_type: Experimental
Sponsor: Dragonfly Therapeutics, Inc.
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: DF-9001
lang: EN
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP