A Phase I/II Study of OBI-999 in People with Solid Tumors

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Full Title

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumor

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug OBI-999 in people with solid tumors that contain a protein called Globo H. The Globo H protein prevents cancer cells from dying and keeps the immune system from recognizing cancer cells. By targeting Globo H, OBI-999 may kill cancer cells and stop the growth and spread of cancer. It is given intravenously (by vein).

Eligibility

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

  • Participants must have a solid tumor that came back or continued to grow despite prior treatment and contains Globo H.
  • At least 3 weeks must pass since the completion of prior therapies and 4 weeks since any major surgery and receipt of OBI-999.
  • 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.

For more information and to ask about eligibility for this study, please contact the office of Dr. Anna Varghese at 646-888-4308.

Protocol

21-205

Phase

I/II

Investigator

Co-Investigators

Diseases