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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

NCT03760081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-11-13

Study results available
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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.

Conditions

  • Incurable Platinum Refractory Germ Cell Tumors
  • Tumors

Interventions

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.

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2020-10-16
Completion
2020-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760081 on ClinicalTrials.gov