NCT03790488

Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies

Phase 1 First in Human Study of Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects With Advanced Refractory Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jounce Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult subjects with advanced refractory solid tumor malignancies, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

Detailed description

JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. This is a Phase 1, first in human, open label, multicenter, dose escalation clinical study to evaluate the safety, tolerability, and PK of JTX-4014 when administered as a single agent to adult subjects with advanced refractory solid tumor malignancies. The intent of this study will be to determine the MTD and RP2D.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	JTX-4014	Specified dose on specified days

Timeline

• Start date: 2018-12-06
• Primary completion: 2019-07-02
• Completion: 2023-02-28
• First posted: 2018-12-31
• Last updated: 2023-07-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study