What side effects are associated with this type of intervention?

Common treatments for metastatic castration-resistant prostate cancer (mCRPC) include targeted therapies, androgen receptor inhibitors, chemotherapy, and radiopharmaceuticals. Targeted therapies and antibody-drug conjugates, like ARX517, often cause side effects such as fatigue, nausea, and potential liver toxicity. Androgen receptor inhibitors, such as enzalutamide and abiraterone, can lead to hypertension, fatigue, and cardiovascular issues. Chemotherapy agents like docetaxel may cause neutropenia, febrile neutropenia, and gastrointestinal symptoms. Radiopharmaceuticals, such as radium-223, are associated with bone marrow suppression and gastrointestinal disturbances. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for metastatic castration-resistant prostate cancer (mCRPC). Notably, enzalutamide, an androgen receptor inhibitor, has shown utility in chemotherapy-naïve men with mCRPC. Radium-223 (Ra-223), a bone-targeting radioisotope, has been used in combination with other therapies like abiraterone and enzalutamide, although its combination with these agents remains experimental. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for PSMA-positive mCRPC patients who have previously been treated with androgen-receptor pathway inhibitors and taxane-based chemotherapy. These treatments highlight the evolving landscape of targeted therapies and radioligand treatments in mCRPC.

What other types of research exist?

Promising novel alternatives to ARX517 for mCRPC patients include: 1) Lutetium-177-PSMA-617, a radiopharmaceutical that targets PSMA-positive cancer cells and has shown improved overall survival in clinical trials. 2) Taxane-based therapies, particularly for AR-V7-positive patients, as they have demonstrated superior survival outcomes compared to ARS-directed therapies. 3) Radium-223, a bone-targeted radioisotope approved for mCRPC with symptomatic bone metastases, which has shown improved overall survival and time to first symptomatic skeletal-related event.

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Protein-Protein Interaction Inhibitor

ARX517 + Enzalutamide for Prostate Cancer (ARX517 Trial)

Phase 1

Recruiting

Research Sponsored by Ambrx, Inc.

Eligibility Criteria Checklist

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

Must have

Ongoing therapy with (and willing to continue with) a gonadotropin-releasing hormone agonist or antagonist (unless prior orchiectomy) AND serum testosterone level < 50 ng/dL at Screening

Histologically confirmed prostate adenocarcinoma

Must not have

Marked baseline prolongation of QT/QT interval corrected for heart rate (QTc), e.g., a triplicate average QTc interval > 480 milliseconds (CTCAE Grade 1) using Fridericia's QT correction formula

Clinically significant ocular findings by a qualified ophthalmologist or optometrist including active ocular infections or chronic corneal disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ARX517, a new drug, in adults with advanced prostate cancer that doesn't respond to usual treatments. The study aims to see if the drug is safe and effective in stopping or slowing down cancer growth.

Who is the study for?

This trial is for adult men with metastatic castration-resistant prostate cancer who have had at least two FDA-approved treatments, including one targeting androgen receptors. They must be on hormone therapy with low testosterone levels and have adequate blood counts. Men with brain metastases needing steroids, significant heart rhythm issues, serious eye conditions, other recent cancers, or lung diseases can't join.

What is being tested?

The study is testing ARX517 alone or combined with other drugs in men with advanced prostate cancer that resists standard hormonal treatment. It's an early-stage trial to see if these treatments are safe and how well patients tolerate them.

What are the potential side effects?

Since this is a phase 1/2 study primarily focused on safety and tolerability, specific side effects of ARX517 aren't listed but may include typical reactions to cancer therapies such as fatigue, nausea, immune system changes, and potential impacts on heart rhythms.

Eligibility Criteria

Inclusion Criteria

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

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I am on hormone therapy for cancer and my testosterone is low.

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My prostate cancer was confirmed through a tissue examination.

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My cancer has spread to other parts of my body.

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My prostate cancer is not responding to hormone therapy.

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I am a man aged 18 or older.

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I have had at least two treatments for prostate cancer, including one that targets hormone receptors.

Exclusion Criteria

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

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My heart's electrical cycle is longer than normal.

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I have serious eye problems confirmed by an eye doctor.

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I have had cancer other than my current one in the last 2 years that needed treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess incidence of adverse events

Secondary study objectives

Area under the serum concentration-time curve (AUC) for ARX517 alone or in combination with ARPIs

Assess changes in serum prostate specific antigen (PSA) levels

Incidence of ADA against ARX517 alone or in combination with ARPIs

+4 more

Other study objectives

Assess changes in Brief Pain Inventory-Short Form (BPI-SF)

Assess changes in Functional Assessment of Cancer Therapy for Patients with Prostate Cancer (FACIT-P)

Evaluate PSMA expression

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: ARX517+ApalutamideExperimental Treatment2 Interventions

ARX517 and apalutamide

Group II: ARX517+AAPExperimental Treatment3 Interventions

ARX517 and abiraterone acetate plus prednisone(AAP)

Group III: ARX517Experimental Treatment1 Intervention

ARX517 will be administered via intravenous (IV) infusion, with the initial treatment regimen by weight-based infusion at an interval of every 3 weeks. Other treatment regimen may be explored.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone acetate

2014

Completed Phase 3

~3440

Prednisone

2014

Completed Phase 4

~2500

Apalutamide

2015

Completed Phase 2

~5750

0 / 9Eligibility criteria met

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

Common treatments for prostate cancer, particularly metastatic castration-resistant prostate cancer (mCRPC), include targeted therapies, androgen receptor inhibitors, chemotherapy, and radiopharmaceuticals. Targeted therapies like ARX517, which is an antibody-drug conjugate, work by specifically targeting cancer cells to deliver cytotoxic agents directly, minimizing damage to healthy cells. Androgen receptor inhibitors (e.g., enzalutamide, apalutamide) block the androgen receptor signaling pathway, crucial for prostate cancer cell growth. Chemotherapy agents like docetaxel disrupt cell division, leading to cancer cell death. Radiopharmaceuticals such as radium-223 deliver targeted radiation to bone metastases, reducing tumor burden. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics and progression.

[177Lu-PSMA therapy : Current evidence for use in the treatment of patients with metastatic prostate cancer].Optimal sequencing of docetaxel and abiraterone in men with metastatic castration-resistant prostate cancer.