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Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

Ovarian Cancer Clinical Trial

Official title:
A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1

Clinical Trial Summary

The purpose of this study is to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.

Clinical Trial Description

The study is comprised of 2 phases. Phase 1 (dose escalation) includes participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1). Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) includes participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who have not responded to Standard of Care (SOC) or are ineligible for standard therapy. Phase 2 single agent will also include a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]). Japanese participants will only be enrolled into the monotherapy arm of the dose expansion cohort. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04939701
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 11, 2022
Completion date June 1, 2023
View Details
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