Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 8:59 AM
Study NCT ID:
NCT03616834
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy
Sponsor:
Effector Therapeutics
Organization:
Study Overview
Official Title:
Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy: A Study of Subjects Administered Anti-PD-1/Anti-PD-L1 Therapy That Are Experiencing Insufficient Response to Checkpoint Inhibitor Alone
Status:
COMPLETED
Status Verified Date:
2019-12
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:
Phase 2, open-label study that will evaluate the safety, tolerability, antitumor activities.
Detailed Description:
This Phase 2, open-label study will evaluate the safety, tolerability, antitumor activity, and pharmacokinetics (PK) of Tomivosertib (eFT-508) in subjects who have initiated anti-PD-1/anti-PD-L1 monotherapy and either developed progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on therapy or have undergone 12 weeks of anti-PD-1/anti-PD-L1 therapy with no evidence of partial response (PR) or complete response (CR).
Study Oversight
Has Oversight DMC:
True
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?: