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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: Recruiting Phase 1 study of Metastatic Castration-resistant Prostate Carcinoma and Metastatic Castration-resistant Prostate Cancer (CRPC), sponsored by TechnoGenesys.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Dose-limiting toxicities are defined in the protocol.
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 |
What NCT06705686 shows while recruiting
NCT06705686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 54-participant average among 8 other Metastatic Castration-resistant Prostate Carcinoma trials with a reported enrollment target (26% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-resistant Prostate Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06705686's enrollment target sits among peer trials
40 5th of 8 higher than 4 of 8 other Metastatic Castration-resistant Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-resistant Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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