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NCT06705686 · ClinicalTrials.gov registry record · Phase 1
Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer
A Phase 1 study of Metastatic Castration-resistant Prostate Carcinoma and Metastatic Castration-resistant Prostate Cancer (CRPC), sponsored by TechnoGenesys.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06705686 is a Phase 1 study of Metastatic Castration-resistant Prostate Carcinoma and Metastatic Castration-resistant Prostate Cancer (CRPC) that is actively recruiting participants, run by TechnoGenesys. The registered enrollment target is 40 participants, below the 54-participant average among 8 other Metastatic Castration-resistant Prostate Carcinoma trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06705686, a Phase 1 study of Metastatic Castration-resistant Prostate Carcinoma and Metastatic Castration-resistant Prostate Cancer (CRPC), is actively recruiting participants, sponsored by TechnoGenesys.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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: Frequenc
Conditions Studied
Interventions
- DRUG (R)-9bMS
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center (UWCCC) - Cancer Connect - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-03-13 |
| Est. Completion | 2028-03-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06705686
The ClinicalTrials.gov registry entry for NCT06705686 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 54-participant average among 8 other Metastatic Castration-resistant Prostate Carcinoma trials with a reported enrollment target (26% lower). The listed sponsor is TechnoGenesys, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Castration-resistant Prostate Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which (R)-9bMS is the first listed.
NCT06705686 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06705686 about?
NCT06705686 is a clinical study titled "Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer". 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 year...
What is the current status of trial NCT06705686?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-03-13. Estimated completion is 2028-03-30.
What conditions does trial NCT06705686 study?
This clinical trial studies the following conditions: Metastatic Castration-resistant Prostate Carcinoma, Metastatic Castration-resistant Prostate Cancer (CRPC).
What interventions are being tested in trial NCT06705686?
The interventions under investigation include: (R)-9bMS (DRUG).
Who is sponsoring clinical trial NCT06705686?
This trial is sponsored by TechnoGenesys, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06705686 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Metastatic Castration-resistant Prostate Cancer (CRPC)
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