Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT02092792
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors
Sponsor:
Genentech, Inc.
Organization:
Study Overview
Official Title:
A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS
Status:
COMPLETED
Status Verified Date:
2020-02
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:
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: