Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

All Conditions

Rare Diseases

Wilms Tumor

Wilms' Tumor

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive ASP7517 on Day 1 of each 28-day cycle for up to 6 doses.

Participants will receive ASP7517 on Day 1 of each 28-day cycle for up to 6 doses in combination with up to 4 doses of pembrolizumab administered every 6 weeks starting from Cycle 1 Day 1. Pembrolizumab monotherapy may be extended up to a total of 17 doses for qualifying participants.

Participants will receive RP2D of ASP7517 on Day 1 of each 28-day cycle for up to 6 doses

Participants will receive RP2D of ASP7517 on Day 1 of each 28-day cycle for up to 6 doses in combination with up to 4 doses of pembrolizumab administered every 6 weeks. Pembrolizumab monotherapy may be extended up to a total of 17 doses for qualifying participants.

ASP7517

Medical Director

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.

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.

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

A Phase 1/2, Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP7517 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express WT1 Antigen

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Events below occurring within 28 days of first dose on Cycle 1 Day 1 (C1D1) and considered related to IP.

Monotherapy:

Non-hematologic AEs grade \>= 3 not resolving to Grade \<=2 within 72 hours of onset; Confirmed Hy's law; Infusion-related reaction (IRR) requiring infusion discontinuation; Treatment-related toxicity with \> 2 weeks delay in initiating Cycle 2 or discontinuation during Cycle 1; Grade \>= 3 anemia requiring transfusion or thrombocytopenia with bleeding requiring transfusion/hospitalization; Grade 3 febrile neutropenia with/without infection; Grade 5 treatment-related toxicity

Combination Therapy:

DLTs mentioned above; Grade \>= 2 pneumonitis, encephalopathy, meningitis, motor/sensory neuropathy; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 x upper limit of normal (ULN) in absence of liver metastases; AST or ALT \> 8 x ULN in presence of liver metastases; Total bilirubin \> 3 x ULN; Guillain-Barre syndrome/myasthenic syndrome/myasthenia gravis

An AE is any untoward medical occurrence in a participant temporally associated with the use of study IP and other study treatments, whether or not considered related to the study IP and other study treatments. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study IP and other study treatments. This includes events related to the comparator and events related to the (study) procedures. AEs will be graded using NCI-CTCAE guidelines, version 5.0.

An AE is considered "serious" if the event: results in death; is life threatening; requires inpatient hospitalization or leads to prolongation of hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; other medically important events.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant 12-lead ECG values.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant physical exam values.

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

iORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed modified Complete Response (iCR) or modified Partial Response (iPR) per iRECIST by independent central review.

ORR is defined as the proportion of participants for each dose level whose best overall response is rated as Complete Response (CR) or Partial Response (PR) per RECIST v1.1.

iDCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed iCR, iPR or stable disease (iSD), per iRECIST.

DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.

iPFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST by independent central review.

iPFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment.

PFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST v1.1 by independent central review.

PFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.

OS is defined as the time from the date of first dose until the date of death from any cause.

iDOR will be calculated only for the subgroup of participants with confirmed response iCR/iPR per iRECIST by independent central review.

iDOR will be calculated only for the subgroup of participants with confirmed response iCR/iPR per iRECIST by investigator assessment.

DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1 by independent central review.

DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1 by investigator assessment.

Spots Global Cancer Trial Database for Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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