A Phase I Study of PT-112 Immunotherapy in Men with Metastatic Castration-Resistant Prostate Cancer

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Full Title

A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects with Advanced Solid Tumors and Subsequent Expansion Cohorts [Cohort D: Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Treated with Three Prior Life-Prolonging Therapies]

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

In this study, researchers are determining the highest dose of an investigational immunotherapy called PT-112 that can be given safely in men with metastatic CRPC. PT112 is a small molecule that may work in multiple ways against cancer, including promoting activation of the immune response and targeting cancer cells that have spread to the bone. PT-112 is 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 metastatic CRPC that continues to grow despite at least three prior therapies, including abiraterone, enzalutamide, apalutamide, or darolutamide as well as taxane chemotherapy.
  • Patients should recover from the serious side effects of previous treatments before receiving PT-112.
  • 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 men ages 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.

Protocol

20-550

Phase

I

Investigator

Co-Investigators