Title
Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9bMS in Patients with Prostate Cancer (PHAROS)

Description
STUDY DESIGN: This phase Ib single-center open-label The PHAROS trial, "Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9bMS in Patients with Prostate Cancer", will establish the safety/tolerability and recommended phase II dosing (RP2D) for (R)-9bMS. Given the unique cancer suppressing properties of the (R)-9bMS compound, its safety and tolerability and proposed Phase 2 dosing will be evaluated in a first-in-human trial in CRPC patients who have stopped responding to Enz or Abi. Post-treatment PSA levels and radiographic responses will be assessed, which will provide preliminary assessment of the efficacy; immune responses will be evaluated, which will provide exploratory assessment immunomodulation.

Objective
OBJECTIVES: Primary Objective: To assess the safety and tolerability of (R)-9bMS in patients with metastatic castration-resistant prostate cancer.

Secondary Objectives: To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of (R)-9bMS in patients with CRPC. To determine the pharmacokinetics (PK) of (R)-9bMS in patients after single and multiple dose oral administration. To assess clinical outcomes and anti-tumor activity in patients treated with (R)-9bMS.

ENDPOINTS: Primary Endpoint: Frequency of dose-limiting toxicities and toxicity and severe AEs per CTCAE v 5.0.

Treatment PHASE: Phase I

DESCRIPTION OF SITES: This study will be open to enrollment at the University of Wisconsin Carbone Cancer Center

DESCRIPTION OF STUDY INERVENTION: (R)-9bMS will be taken by mouth twice daily until completion of 12 cycles, progression or intolerance

STUDY DURATION: 12 months for enrollment + 12 months treatment + 12 months follow-up + 12 months for data analysis = 48 months.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital