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Tyrosine Kinase Inhibitor

(R)-9bMS for Prostate Cancer (PHAROS Trial)

Phase 1

Waitlist Available

Research Sponsored by TechnoGenesys, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have evidence of castrate testosterone levels with baseline serum testosterone level of 50 ng/dL or less at time of study start, and castrate levels should be maintained throughout study

At least 18 years of age

Must not have

History of seizures or seizure disorder

Inability to swallow pills

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment through the completion of follow-up (up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug called (R)-9bMS in patients with advanced prostate cancer. The drug has shown promising results in preclinical studies by suppressing tumor growth and activating the immune

Who is the study for?

This trial is for adults with metastatic castration-resistant prostate cancer. Participants must have a confirmed diagnosis and may not have had previous treatments that would conflict with the study drug. The trial excludes individuals who cannot take oral medication or have conditions that could interfere with the study outcomes.

What is being tested?

(R)-9bMS, an ACK1 inhibitor taken orally twice daily, is being tested in this Phase I trial to evaluate its safety and effectiveness against prostate cancer. The study will also determine the maximum tolerated dose and observe any potential anti-tumor responses over a period including treatment and follow-up.

What are the potential side effects?

Potential side effects of (R)-9bMS are currently under investigation in this Phase I trial. Common side effects from similar medications include digestive issues, fatigue, skin reactions, blood disorders, but specific side effects related to (R)-9bMS will be determined based on observed adverse events during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My testosterone levels are very low and will stay that way during the study.

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I am 18 years old or older.

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My prostate cancer is confirmed by lab tests.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am currently on hormone therapy for cancer or have been surgically castrated.

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My prostate cancer is worsening despite treatment, shown by rising PSA levels or scans.

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My cancer progressed despite treatment with drugs like enzalutamide or abiraterone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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I cannot swallow pills.

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I have received an organ transplant from another person.

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I haven't taken any kinase inhibitor medication in the last 14 days.

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My prostate cancer is not the common adenocarcinoma type.

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I am not starting new bone treatments after beginning the study drug, but can continue any I already started.

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I have fully healed from any major surgery at least one month before starting the study treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through the completion of follow-up (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through the completion of follow-up (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through the completion of follow-up (up to 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of dose-limiting toxicities (Dose Escalation only)

Secondary study objectives

Change in pharmacokinetic parameters as measured by half life of drug in blood

Disease specific survival (DFS)

Duration of response (DoR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Expansion: (R)-9bMSExperimental Treatment1 Intervention

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.

Group II: Dose Escalation: (R)-9bMSExperimental Treatment1 Intervention

Patient will take the assigned dose of (R)-9bMS twice daily by mouth for up to 6 months. Each cycle is 28 days.

0 / 14Eligibility criteria met