A Phase I Study of SM08502 in People with Advanced Prostate Cancer

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Full Title

A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects with Advanced Solid Tumors (SM08502-ONC-01)

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). One of the ways prostate cancer becomes resistant to treatment is by building alternative pathways to activate testosterone.

The purpose of this study is to assess the safety of the investigational drug SM08502 in men with CRPC. SM08502 blocks a protein called CLK, which plays a role in the formation of alternative receptors for testosterone. These alternative receptors may drive CRPC growth. By blocking this protein, SM08502 may help stop the growth of new cancer cells. It is taken orally (by mouth).

Eligibility

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

  • Participants must have CRPC that continues to grow despite treatment.
  • Patients’ prostate tumor cells must show a specific testosterone receptor variant called AR-v7. Patients will receive testing for this variant as part of the trial.
  • The serious side effects of prior therapies must go away before the study treatment is given.
  • 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. Daniel Danila at 646-422-4612.

Protocol

21-521

Phase

I

Investigator

Co-Investigators