A Phase I Study of PF-06688992 in Patients with Inoperable or Metastatic Melanoma

Full Title

IIT: A Phase I Open-Label Dose Escalation and Expansion Study of GD3 ADC (Pfizer PF-06688992) in Subjects with Unresectable Stage III or Stage IV Malignant Melanoma (B802WI209568)

Purpose

The purpose of this study is to find the highest dose of the investigational drug PF-06688992 that can be given safely in patients with inoperable (stage III) or metastatic (stage IV) melanoma. PF-06688992 is an “antibody-drug conjugate.” It consists of an antibody that binds to GD3 on melanoma cells, connected to a drug (PF-06464368) that is released in the tumor. Doctors hope this will lead to killing of melanoma cells with fewer side effects than traditional chemotherapy.

Eligibility

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

  • Patients must have stage III or IV melanoma that has continued to grow despite prior treatment, such as immunotherapy or a RAF inhibitor.
  • Any brain metastases must have been treated and remained stable for 2 weeks.
  • At least 2 weeks must pass between the completion of previous therapy 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 Dr. Paul Chapman at 646-888-4162.

Protocol

17-165

Phase

I

Investigator

Co-Investigators

Diseases