A Phase I Study of ELU001 in People Who Have Solid Tumors Associated with High Levels of FR-Alpha

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Full Title

Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects who have Advanced, Recurrent or Refractory FRa Overexpressing Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug ELU001 that can be given safely in people with solid tumors that have been associated with making too much of a protein called folate receptor alpha (FR-alpha). ELU001 targets and attaches to cancer cells that make this protein and delivers an anticancer drug called exatecan directly to the cells, which is designed to stop the growth of cancer cells and kill them. ELU001 is given intravenously (by vein).

Who Can Join

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

  • Participants must have a solid tumor (including ovarian, endometrial, colorectal, gastroesophageal junction, gastric, breast, non-small cell lung, or bile duct cancer) that cannot be successfully treated with existing therapies.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • 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. Yonina Murciano-Goroff at 646-888-4226.

Protocol

22-077

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Co-Investigators

ClinicalTrials.gov ID

NCT05001282