A Phase I Study of PF-07062119 Immunotherapy in People with Advanced Digestive Cancers

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Full Title

A Phase 1 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07062119 in Patients with Advanced Gastrointestinal Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug PF-07062119 that can be given safely in patients with advanced colorectal, esophageal, or gastric (stomach) cancers. PF-07062119 is a “bispecific antibody.” It is designed to attach to two different proteins at the same time: one protein on the surface of cancer cells, and the other on the surface of T cells (immune cells).

Researchers think that PF-07062119 may strengthen the immune system by activating immune cells to destroy the tumor. PF-07062119 is given as a subcutaneous injection into the skin of the abdomen.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced colorectal, esophageal, or gastric cancer that cannot be successfully treated with standard therapies.
  • At least 3 weeks must pass since prior radiation therapy or major surgery and 4 weeks since the completion of chemotherapy and receipt of PF-07062119.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Neil Segal at 646-888-4187.

Protocol

20-345

Phase

I

Investigator

Co-Investigators