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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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart's electrical cycle is longer than normal.
Select...
I have serious eye problems confirmed by an eye doctor.
Select...
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
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 moreOther 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 moreAwards & 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
Apalutamide
2015
Completed Phase 2
~5750
Prednisone
2014
Completed Phase 4
~2500
Abiraterone acetate
2014
Completed Phase 3
~3440
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.
[<sup>177</sup>Lu-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.
[<sup>177</sup>Lu-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.
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Who is running the clinical trial?
Johnson & JohnsonIndustry Sponsor
112 Previous Clinical Trials
163,329 Total Patients Enrolled
1 Trials studying Prostate Cancer
42 Patients Enrolled for Prostate Cancer
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's electrical cycle is longer than normal.I am on hormone therapy for cancer and my testosterone is low.I have serious eye problems confirmed by an eye doctor.My prostate cancer was confirmed through a tissue examination.I haven't had lung diseases like interstitial lung disease or pneumonitis in the last year.My cancer has spread to other parts of my body.My brain metastasis was treated, is stable for 2 months, and I'm not on steroids.My prostate cancer is not responding to hormone therapy.I am a man aged 18 or older.My blood counts are within a healthy range.I have had at least two treatments for prostate cancer, including one that targets hormone receptors.I have had cancer other than my current one in the last 2 years that needed treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ARX517
- Group 2: ARX517+Apalutamide
- Group 3: ARX517+AAP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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