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

{ "Phase 1 Study of (R)-9bMS for Metastatic Prostate Cancer", "This study is testing a new drug called (R)-9bMS for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. (R)-9bMS works by targeting a specific protein called ACK1, which can contribute to prostate cancer growth. The main goal of this study is to find out how safe (R)-9bMS is and what dose can be given without causing too many side effects. You may be able to join if you have mCRPC that has spread, and your cancer has been confirmed by a biopsy. The study plans to enroll 40 participants.", "design": "This is a Phase 1, single-center, open-label study, meaning everyone knows what treatment is being given. It aims to enroll 40 participants.", "commitments": "(R)-9bMS will be given orally on day 1 (two doses, 12 hours apart) and day 2 (one dose, 12 hours after the second day 1 dose). You will be admitted overnight for these first three doses.", "compensation": "Not stated in the trial record.", "follow_up": "The frequency of dose-limiting toxicities will be measured from day 1 through day 28 of treatment.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 18+InterventionalTreatment

TechnoGenesys, Inc.

~40 participants

Updated 2026-03-20 on ClinicalTrials.gov

What's tested:(R)-9bMS

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Frequency of dose-limiting toxicities (Dose Escalation only)

Measured over From day 1 of treatment through day 28 of treatment

Conditions

Metastatic Castration-resistant Prostate Cancer (CRPC)

Metastatic Castration-resistant Prostate Carcinoma

Where it's being run

1 sites across 1 states

Wisconsin1

Study leadership

Douglas McNeel, MD, PhD · STUDY_DIRECTOR · University of Wisconsin, Madison

Who to contact

Nupam Mahajan, PhD

[email protected]

8135074903

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Absolute neutrophil count ≥ 1,500/mm3 without granulocyte colony-stimulating factor support

White blood cell count ≥ 2,000/mm3

Platelets ≥ 100,000/mm3 without transfusion

Hemoglobin ≥ 9.0 g/DL

Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3.0 x IULN)

AST(SGOT), ALT(SGPT) ≤ 3.0 x IULN

Serum creatinine ≤ 1.5 x IULN or calculated creatinine clearance ≥ 45 mL/min by Cockcroft-Gault

Serum albumin ≥ 2.8 g/dL

Urine protein/creatinine ration (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) (only evaluated if creatinine abnormal per criteria above

PT/INR or PTT \< 1.5 x IULN (PT/INR must be drawn \< 7 days prior to biopsy for those patients treated in MTD cohort), unless participant is receiving anticoagulant therapy and these are within intended therapeutic ranges for anticoagulant. 12. Corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 500 ms (by ECG). 13. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of the legally authorized representative, if applicable). 14. Willingness and ability to undergo biopsy for research component of the trial (for patients treated in MTD cohort) 15. Heterosexually active male patients (along with their female partners) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and for 5 months following the last day of study treatment. If a female partner of a male patient becomes pregnant during therapy or within 5 months after the last day of study treatment, the investigator must be notified in order to facilitate outcome follow-up.

Exclusion

Cardiovascular disorders:

Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.

Uncontrolled hypertension defined as sustained blood pressure (BP) \> 160 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment.

Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within six months before the first dose of study treatment.

Subjects with a diagnosis of incidental, subsegmental PE or DVT within six months are allowed if stable, asymptomatic, and treated with anticoagulation for at least 1 week before the first dose of study treatment.

Gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation, as determined by the PI:

The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.

Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within six months before the first dose.

Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before the first dose.

Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.

Lesions invading or encasing any major blood vessels.

Other clinically significant disorders that would preclude safe study participation.

Serious non-healing wound/ulcer/bone fracture.

Uncompensated/symptomatic hypothyroidism.

Moderate to severe hepatic impairment (Child-Pugh B or C). 17. Active hepatitis B or C or active HIV per review of medical records. Patients with well-controlled HIV or hepatitis B or C, or who have had curative treatment for hepatitis C, may be considered if they meet all other criteria and after discussion with the PI using the following criteria for guidance:

What this trial measures

Frequency of dose-limiting toxicities (Dose Escalation only)From day 1 of treatment through day 28 of treatment
Dose-limiting toxicities are defined in the protocol.

Trialytics