What is the mechanism of action of this treatment?

Prostate cancer treatments often target specific enzymes and pathways critical for cancer cell growth and survival. Enzyme inhibitors, like the investigational drug M1774, work by blocking enzymes necessary for tumor cell proliferation, potentially leading to tumor shrinkage or stabilization. Other common treatments include androgen deprivation therapy (ADT), which reduces levels of male hormones that fuel cancer growth, and chemotherapy, which kills rapidly dividing cells. Understanding these mechanisms helps patients appreciate how these therapies can control cancer progression and improve outcomes.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving enzyme inhibition like M1774, often have side effects such as fatigue, nausea, anemia, and gastrointestinal issues like constipation and diarrhea. Other frequently reported adverse events include anorexia, vomiting, and elevated transaminases. These side effects are consistent with those observed in various treatments for castration-resistant prostate cancer (CRPC), including those targeting specific enzymes or pathways involved in tumor growth and progression.

What prior FDA approvals exist?

The FDA has approved several enzyme inhibitors for the treatment of prostate cancer, particularly metastatic castration-resistant prostate cancer (mCRPC). Notable among these are abiraterone acetate, an androgen synthesis inhibitor, and enzalutamide, an androgen receptor inhibitor. These drugs work by blocking the enzymes necessary for androgen production or action, thereby inhibiting tumor growth. These treatments have shown significant efficacy in clinical trials and are widely used in managing advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to M1774 for prostate cancer patients include: 1) NLG207 in combination with enzalutamide, which has shown effectiveness in preclinical models of enzalutamide-resistant prostate cancer and is currently under clinical investigation. 2) BAT (Bipolar Androgen Therapy), which has demonstrated potential in restoring sensitivity to abiraterone and enzalutamide in castration-resistant prostate cancer (CRPC). 3) 177Lu-PSMA-RLT, a radioligand therapy that has shown encouraging results in extending overall survival in metastatic CRPC with a favorable toxicity profile.

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Enzyme Inhibitor

Tuvusertib for Refractory Prostate Cancer

Phase 2

Recruiting

Led By Jacob Orme

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from registration date

Awards & highlights

No Placebo-Only Group

Summary

This trial tests M1774, a drug taken by mouth, in patients with hard-to-treat prostate cancer with a specific genetic mutation. The drug aims to stop cancer cells from growing by blocking enzymes they need. It could help shrink or stabilize these difficult-to-treat tumors.

Who is the study for?

This trial is for adults with hard-to-treat prostate cancer that has a specific SPOP gene mutation. Participants must have measurable disease, be on hormone therapy or surgically castrated, and have adequate organ function. People with controlled HIV or hepatitis are eligible; those with certain heart conditions may join after assessment. Women of childbearing potential and men must agree to use contraception.

What is being tested?

The trial tests M1774's effectiveness in shrinking or stabilizing refractory SPOP-mutant prostate cancer by inhibiting enzymes needed for tumor cell growth. It involves various assessments like biospecimen collection, imaging (ultrasound, CT, MRI, PET), and biopsy to monitor the treatment's impact.

What are the potential side effects?

While not explicitly listed here, side effects likely include reactions related to enzyme inhibition which could affect cell growth in the body leading to fatigue, gastrointestinal issues, blood count changes and potentially impact organ functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from registration date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from registration date

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from registration date for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response rate

Secondary study objectives

Incidence of adverse events (AE)

Overall Survival

Progression Free Survival (PFS)

Other study objectives

Overall SPOP-driven gene signature changes

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tuvusertib)Experimental Treatment7 Interventions

Patients receive tuvusertib PO QD on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, MRI, CT, PET/MRI, PET/CT or U/S and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Ultrasound Imaging

2018

Completed Phase 4

~760

Positron Emission Tomography

2011

Completed Phase 2

~2200

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2740

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target specific enzymes and pathways critical for cancer cell growth and survival. Enzyme inhibitors, like the investigational drug M1774, work by blocking enzymes necessary for tumor cell proliferation, potentially leading to tumor shrinkage or stabilization. Other common treatments include androgen deprivation therapy (ADT), which reduces levels of male hormones that fuel cancer growth, and chemotherapy, which kills rapidly dividing cells. Understanding these mechanisms helps patients appreciate how these therapies can control cancer progression and improve outcomes.