A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors

MC #23-04

NCT #
Condition(s)
Breast Cancer, Colorectal Cancer, Lung Cancer (NSCLC), Ovarian/ Peritoneal/ Fallopian Tube Cancer, Prostate Cancer, Urothelial Cancer
Molecular Target(s)
CD137, CLDN4
Drug Classification(s)
Immunotherapy
Agents(s)
ASP1002
Phase(s)
I

Mechanism of Action

  • ASP1002 is anti-CLDN4 and anti-CD137 bispecific antibody

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study agent can be given with an acceptable level of side effects
  • The effects of the study agent (good and bad)
  • How much of the study agent is absorbed into the blood and how fast it is removed
  • How the study agent is acting on your body
  • If research tests can be used in the future to predict who will benefit from ASP1002

Study Design

If you can take part in this study, your study doctor may enroll you into 1 of 2 treatment groups for your specific tumor type. If enrollment for both treatment groups within a specific tumor type is open at the same time, you will have a 1 in 2 chance of being randomized into either treatment group.

The treatment period will take up to 32 Cycles (approximately 2 years) to complete. A cycle in this study is 21 days. You will receive ASP1002 once every week on days 1, 8, and 15 of each cycle via intravenous (IV) infusion. If you complete all dosing treatments, this means you will make about 96 weekly visits to the hospital or clinic. You must stay at the site facility for 4 hours following your infusion of ASP1002 on Cycles 1 and 2.  For all other cycles, you will stay at your site facility for 2 hours after your infusion.

You may continue study treatment beyond 2 years if your study doctor considers this to be in your best interest and is approved by the Sponsor.

Location

Mary Crowley Cancer Research - Medical City Dallas

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