NCT03616834

Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Effector Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Tomivosertib (eFT-508)	Tomivosertib (eFT-508) is a novel, small-molecule investigational drug being developed by eFFECTOR Therapeutics, as an antitumor therapy that acts by selectively inhibiting mitogen-activated protein kinase (MAPK)-interacting serine/threonine kinase (MNK)1 and MNK 2.

Timeline

• Start date: 2018-07-25
• Primary completion: 2021-01-31
• Completion: 2021-06-30
• First posted: 2018-08-06
• Last updated: 2023-03-22

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study