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Clinical trial

Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (SELECT)

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Last updated:3rd Jun 2021
Status: Recruiting
Identifier: NCT04549025
Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (SELECT)


Brief Summary:

This is a Phase 2, open-label study to evaluate PD-1 inhibitor JTX-4014 alone and in combination with vopratelimab, an ICOS agonist, in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen.

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. Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 2, open label study to evaluate the efficacy, safety, tolerability of JTX-4014 alone and in combination with vopratelimab in biomarker-selected adult subjects with metastatic NSCLC who are PD-1/PD-L1 inhibitor naïve and have progressed on a platinum based chemotherapy regimen


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen
Actual Study Start Date: October 19, 2020
Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: March 2023

Arm:
- Experimental: JTX-4104
- Experimental: JTX 4014 in combination with vopratelimab (dose level 1)
- Experimental: JTX 4014 in combination with vopratelimab (dose level 2)


Category Value
Study type(s) Interventional
Estimated enrolment 75
Actual Study start date 19 October 2020
Estimated Study Completion Date 01 March 2023

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