A Phase I Study of ASP3082 in People with Solid Tumors with KRAS G12D Mutations

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Full Title

A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

Purpose

The purpose of this study is to find the highest dose of the investigational drug ASP3082 that can be given safely in people with inoperable or metastatic solid tumors that contain a mutation called KRAS G12D. ASP3082 targets the KRAS G12D mutation, blocking its ability to send signals that turn on cancer cells and cause them to grow and spread. It is given intravenously (by vein) through a central venous port on a weekly schedule. 

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have a solid tumor that is locally advanced or metastatic and has a KRAS G12D mutation.
  • Patients must have a tumor that is able to be biopsied safely during the study.
  • At least 3 weeks must pass since the completion of prior anticancer treatment (2 weeks since radiation therapy) and receipt of ASP3082.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Wungki Park at 646-888-4543.

Protocol

22-310

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Diseases

ClinicalTrials.gov ID

NCT05382559