NCT03760081

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

A Phase 2, Open-Label, Single-Arm, Multicenter 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consisted of 2 phases: Safety Lead-in phase and phase 2. 19 participants were enrolled in both phases. The Safety Lead-in phase of this study was to establish the tolerability of RP2D. The RP2D determination was based on at least 6 evaluable participants at the RP2D as determined by the Dose Evaluation Committee (DEC). Once RP2D had been established as tolerable, 13 additional participants were enrolled in phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation criteria had been met, whichever occurred earlier.

Conditions

• Incurable Platinum Refractory Germ Cell Tumors
• Tumors

Interventions

Type	Name	Description
DRUG	ASP1650	Participants received ASP1650 dose level 1 or dose level 2 as intravenous infusion, Q2W starting on C1D1 for up to a maximum of 12 cycles or until study discontinuation criterion was met, whichever occurred earlier. Duration of each treatment cycle was 14 days.

Timeline

• Start date: 2019-03-19
• Primary completion: 2020-10-16
• Completion: 2020-10-16
• First posted: 2018-11-30
• Last updated: 2024-11-13
• Results posted: 2021-11-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study