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Protein-Protein Interaction Inhibitor

ARX517 + Enzalutamide for Prostate Cancer (ARX517 Trial)

Q: Has ARX517 received regulatory endorsement from the FDA?

Due to the limited data supporting both safety and efficacy, ARX517 received a score of 1.

Q: What is the ceiling for enrollment in this research project?

76 participants that fit the established criteria need to partake in this experiment. Individuals can provide their services from Urology <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center, XCancer Research Network based out of Omaha, <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a> and University of <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> Comprehensive Cancer Centre situated in Ann Arbor, Michigan.

Q: Is there still room to join this medical experiment?

Data on clinicaltrials.gov indicates that this research is actively looking for volunteers, with initial posting taking place at the end of April 2021 and a final edit occurring in early November 2022.

Q: What is the breadth of locations where this research project is unfolding?

At present, 8 clinical trial sites are taking patients. These locations consist of Omaha, Ann Arbor and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City with the rest spread throughout different cities. To lessen travel obligations for enrollees, it is beneficial to choose a facility close by your residence.

Q: What results are researchers hoping to glean from this experiment?

According to Ambrx Inc., the principle end goal of this 1.5-year trial is ascertaining ARX517's safety and tolerability by monitoring multi cycle use of the drug. Furthermore, secondary objectives include evaluating the pharmacokinetics (PK) profiles for both free payload pAF-AS269 and antibody drug conjugates (ADC), as well as assessing anti-drug antibodies (ADA).

Phase 1 & 2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

ARX517 Trial Summary

This trial is testing a new drug, ARX517, to see if it is safe and effective in treating patients with advanced solid tumors that have failed other treatments.

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.Check my eligibility

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.See study design

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.

ARX517 Trial 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.

Select...

My prostate cancer was confirmed through a tissue examination.

Select...

My cancer has spread to other parts of my body.

Select...

My prostate cancer is not responding to hormone therapy.

Select...

I am a man aged 18 or older.

Select...

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

ARX517 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Assess incidence of adverse events

Secondary outcome measures

Assess changes in serum prostate specific antigen (PSA) levels

Overall survival (OS)

Phase 1: Area under the serum concentration-time curve (AUC) for ARX517

+7 more

Other outcome measures

Phase 1: Assess changes in Brief Pain Inventory-Short Form

Phase 1: Assess changes in Functional Assessment of Cancer Therapy for Patients with Prostate Cancer (FACIT-P)

Phase 1: Evaluate PSMA expression

+1 more

ARX517 Trial Design

1Treatment groups

Experimental Treatment

Group I: ARX517 Alone and Combination Cohorts (Phase 1)Experimental Treatment2 Interventions

Monotherapy: ARX517 will be administered via intravenous (IV) infusion every 3, or 4 weeks. Combination Cohorts: ARX517 + enzalutamide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ambrx, Inc.Lead Sponsor

7 Previous Clinical Trials

508 Total Patients Enrolled

AmbrxStudy DirectorAmbrx, Inc.

2 Previous Clinical Trials

177 Total Patients Enrolled

Media Library

ARX517 (Protein-Protein Interaction Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04662580 — Phase 1 & 2

Prostate Cancer Research Study Groups: ARX517 Alone and Combination Cohorts (Phase 1)

Prostate Cancer Clinical Trial 2023: ARX517 Highlights & Side Effects. Trial Name: NCT04662580 — Phase 1 & 2

ARX517 (Protein-Protein Interaction Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662580 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ARX517 received regulatory endorsement from the FDA?

"Due to the limited data supporting both safety and efficacy, ARX517 received a score of 1."

Answered by AI

What is the ceiling for enrollment in this research project?

"76 participants that fit the established criteria need to partake in this experiment. Individuals can provide their services from Urology Cancer Center, XCancer Research Network based out of Omaha, Nebraska and University of Michigan Comprehensive Cancer Centre situated in Ann Arbor, Michigan."

Answered by AI

Is there still room to join this medical experiment?

"Data on clinicaltrials.gov indicates that this research is actively looking for volunteers, with initial posting taking place at the end of April 2021 and a final edit occurring in early November 2022."

Answered by AI

What is the breadth of locations where this research project is unfolding?

"At present, 8 clinical trial sites are taking patients. These locations consist of Omaha, Ann Arbor and New york City with the rest spread throughout different cities. To lessen travel obligations for enrollees, it is beneficial to choose a facility close by your residence."

Answered by AI

What results are researchers hoping to glean from this experiment?

"According to Ambrx Inc., the principle end goal of this 1.5-year trial is ascertaining ARX517's safety and tolerability by monitoring multi cycle use of the drug. Furthermore, secondary objectives include evaluating the pharmacokinetics (PK) profiles for both free payload pAF-AS269 and antibody drug conjugates (ADC), as well as assessing anti-drug antibodies (ADA)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer

2021. "ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04662580.

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