ASP7517 / Riken, Astellas - LARVOL DELTA

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2027 ➔ Jun 2024 | Trial primary completion date: Dec 2027 ➔ Jun 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=43 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Jun 2023 | Trial primary completion date: Feb 2024 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | N=385 ➔ 24

Combination therapy • Enrollment change • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=43 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Oct 2023 ➔ Feb 2024 | Trial primary completion date: Oct 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2 | N=385 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=43 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting | N=122 ➔ 43

Enrollment change • Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Nov 2024 ➔ Nov 2023 | Trial primary completion date: Nov 2024 ➔ Nov 2023

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Jul 2025 ➔ Nov 2024 | Trial primary completion date: Jul 2025 ➔ Nov 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2; N=385; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Initiation date: Jul 2021 ➔ Dec 2021

Clinical • Combination therapy • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2; N=385; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=122; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Mar 2023 ➔ Dec 2024; Trial primary completion date: Mar 2023 ➔ Dec 2024

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (clinicaltrials.gov) - P1/2; N=385; Not yet recruiting; Sponsor: Astellas Pharma Global Development, Inc.

New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • BRAF • EGFR • WT1

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=128; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=122; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P1/2; N=122; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open