Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04143711
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2019-10-18
Brief Title:
Study of DF1001 in Patients With Advanced Solid Tumors
Sponsor:
Dragonfly Therapeutics
Organization:
Dragonfly Therapeutics
Study Overview
Official Title:
A Phase III First-In-Human Multi-Part Open-Label Multiple-Ascending Dose Study to Investigate the Safety Tolerability Pharmacokinetics Biological and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors and Expansion in Selected Indications
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None