ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer

NCT01963052 ↗

Phase 1 Completed 93 enrolled Astellas Pharma Global Development, Inc. Seagen Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease.

Timeline

Start: 2013-11-14
Primary completion: 2019-07-08
Completion: 2019-07-08

Publications

Petrylak DP, Eigl BJ, George S, Heath EI, Hotte SJ, Chism DD, Nabell LM, Picus J, Cheng SY, Appleman LJ, Sonpavde GP, Morgans AK, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu EY. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024 Jan 5;30(1):63-73. doi: 10.1158/1078-0432.CCR-22-3627.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AGS15E	Other / unclassified	0.1 mg/kg	Intravenous
Subject	AGS15E	Other / unclassified	0.25 mg/kg	Intravenous
Subject	AGS15E	Other / unclassified	0.5 mg/kg	Intravenous
Subject	AGS15E	Other / unclassified	0.75 mg/kg	Intravenous
Subject	AGS15E	Other / unclassified	1 mg/kg	Intravenous
Subject	AGS15E	Other / unclassified	1.25 mg/kg	Intravenous

ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer

Summary

Timeline

Publications

Drugs

Indications