A Phase I Study of Immunotherapy with Emactuzumab and RO7009789 in Patients with Advanced Solid Tumors

Full Title

BP29427: An Open-Label, Multicenter, Dose-Escalation Phase IB Study with Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients with Advanced Solid Tumors

Purpose

In this study, researchers are finding the highest doses of two investigational immunotherapy drugs, emactuzumab and RO7009789, when they are given together in patients with advanced solid tumors. Investigators believe that using both drugs together can improve the ability of the immune system to recognize and kill cancer cells.

RO7009789 prompts immune cells to attack cancer cells by activating a protein on immune cells called CD40. Emactuzumab blocks a protein called CSF1-R on white blood cells called M2 macrophages, which cause cancer cells to grow. It is hoped that by blocking CSF1-R and activating CD40, RO7009789 and emactuzumab may stop cancers from growing. Both drugs are given intravenously (by vein).

Eligibility

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

  • Patients must have advanced triple-negative breast cancer, ovarian cancer, pancreatic cancer, gastric (stomach) cancer, colorectal cancer, melanoma, or mesothelioma that cannot be successfully treated using standard therapies.
  • At least 3 weeks must pass between the completion of previous therapies (4 weeks since other investigational treatments) and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 the Immunotherapeutics Clinic at 646-888-3359.

Protocol

16-1010

Phase

I

Investigator

Co-Investigators

Locations