Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen

Active:	No
Cancer Type:	Colon/Rectal Cancer Melanoma Ovarian Cancer	NCT ID:	NCT04837196
Trial Phases:	Phase I Phase II	Protocol IDs:	7517-CL-1101 (primary) NCI-2021-06479
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Astellas Pharma Global Development, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04837196

Summary

The purpose of this study is to evaluate the safety, tolerability, and clinical response
of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum
Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination
with pembrolizumab.

This study will also evaluate other measures of anticancer activity of ASP7517 when
administered as a single agent and in combination with pembrolizumab based on central and
local assessment.

Objectives

This study consists of arms receiving ASP7517 monotherapy and arms receiving ASP7517 and
pembrolizumab combination therapy in Phase 1 (dose escalation cohort) and Phase 2 (dose
expansion cohort). Phase 2 monotherapy and combination dose expansion cohorts will be
opened after the phase 1 escalation cohort has been completed.

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