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

Study on Investigational Medication for Germ Cell Tumors

Recruiting
18 years - 100 years
Male
1 Location

Brief description of study.

The purpose of this study is 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.

Detailed description of study

This study will also evaluate 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Germ Cell Tumor
  • Age: 18 years - 100 years
  • Gender: Male

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
  • Subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
  • A male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1811204023 (1650-CL-0201)

This study investigates the effectiveness of an investigational medication for treating germ cell tumors that do not respond to platinum-based treatments. Germ cell tumors are a type of cancer that begins in the cells that develop into sperm or eggs. The purpose of the study is to find the best dose for phase 2 and to measure how well the medication works in shrinking tumors.

Participants will receive the investigational medication and undergo various tests to see how their tumors respond. The study will look at different measures of effectiveness, such as how long the response lasts and how the disease progresses. It will also monitor the safety and side effects of the medication, as well as its effects on certain proteins in the blood.

  • Who can participate: Eligible participants are men who must use contraception or remain abstinent during the study and for 6 months after. They should also comply with specific requirements if their partner is pregnant or breastfeeding.
  • Study details: Participants will receive the investigational medication and will be monitored for changes in their condition. A placebo will not be used in this study. The study will include tests to measure the effects of the medication on blood proteins and tumor response.

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