A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors

Summary

The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in participants with incurable platinum refractory germ cell tumors. This study also evaluated the following efficacy measures for confirmed objective response rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the pharmacokinetics of ASP1650.

Timeline

Start

2019-03-19

Primary completion

2020-10-16

Completion

2020-10-16

Outcome

Missed primary endpoint

paper No partial or complete responses were observed. PMID 35759134 ↗

paper The study was stopped at the end of Simon Stage-I due to lack of efficacy. PMID 35759134 ↗

Publications

• Adra N, Vaughn DJ, Einhorn LH, Hanna NH, Funt SA, Rosales M, Arozullah A, Feldman DR. A phase II study assessing the safety and efficacy of ASP1650 in male patients with relapsed refractory germ cell tumors. Invest New Drugs. 2022 Oct;40(5):1087-1094. doi: 10.1007/s10637-022-01276-w. Epub 2022 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP1650	Monoclonal antibody	1000 mg/m2	Intravenous
Subject	ASP1650	Monoclonal antibody	1500 mg/m2	Intravenous

Indications