Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
TechnoGenesys, Inc.
Study ID
NCT06705686
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Castration-resistant Prostate Cancer (CRPC)
  • Metastatic Castration-resistant Prostate Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (R)-9bMS — DRUG
    (R)-9bMS will be given in clinic on day 1, two doses 12 hours (+/- 30 minutes) apart, and on day 2, 12 hours (+/- 30 minutes) after the second day 1 dose. Patients will be admitted overnight for these first 3 doses. Patient must be fasting 1 hour before and 1 hour after doses for these first 3 doses. (R)-9bMS should be taken with a glass of water. Patients will be dispensed home supply after C1D2 morning dose.

Study Details

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) STUDY DESCRIPTION: Prostate cancer (PC) patients receive androgen deprivation therapy (ADT), but recalcitrant disease recurs typically within 2-3 years, referred to as the Castration Resistant Prostate Cancer (CRPC). Androgen receptor (AR) targeted therapies, such as Enzalutamide (Enz) or Abiraterone (Abi), are FDA-approved therapeutics for CRPC patients. However, virtually all patients develop resistance. A non-receptor tyrosine kinase, ACK1 act as a novel epigenetic modifier in prostate tumors, regulating AR and its splice variant, AR-V7 expression. A new class of ACK1 small molecule inhibitor, (R)-9bMS, was developed that exhibited excellent drug-like properties. Treatment with (R)-9bMS suppressed Abi and Enz-resistant tumor growth in mice. Robust immune activation against prostate tumors was also reflected in mice treated with ACK1 inhibitor, (R)-9bMS. Importantly (R)-9bMS functionally reinvigorated peripheral blood mononuclear cells (PBMCs) of CRPC patients to mount a robust immune response against CRPC organoids. Collectively, these data indicate that the ACK1 inhibitor, (R)-9bMS, fulfills a unique niche, wherein it not only suppressed AR/AR-V7 within the tumor milieu, but also activated host immune system by overcoming CSK-restrained LCK activity, to mount a robust 'dual' anti-tumor response. 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. Secondary Endpoints: * RP2D (recommended phase 2 dose) * PK (pharmacokinetics) * PSA responses * Duration of responses * ORR (objective response rate) * OS (overall survival) * PFS (progression free survival) * DSS (disease specific survival) * Toxicity and severe AEs per CTCAE v 5.0 STUDY POPULATION: Approximately 18-30 adult patients with a histologic or cytologic diagnosis of metastatic castration resistant prostate cancer will be enrolled. 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 Dates

First listed
Nov 26, 2024
Start date
Mar 13, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: (R)-9bMS
    Patient will take the assigned dose of (R)-9bMS twice daily by mouth for up to 6 months. Each cycle is 28 days.
  • Experimental: Expansion: (R)-9bMS
    Patient will take (R)-9bMS twice daily by mouth for up to 6 months. Each cycle is 28 days. The assigned dose will be determined in the Dose Escalation portion of the trial.

Primary Outcome Measure

Frequency of dose-limiting toxicities (Dose Escalation only) [ Time Frame: From day 1 of treatment through day 28 of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer Center (UWCCC) - Cancer ConnectMadisonWisconsin53792
UW Clinical Trial Navigation Team UW Clinical Trial Navigation Team
[email protected]
800-622-8922
Douglas McNeel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin Carbone Cancer Center (UWCCC) - Cancer Connect· Madison, WI

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