Evaluating ARX517 for metastatic prostate cancer treatment
A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 as Monotherapy and in Combination With Androgen Receptor Pathway Inhibitors in Subjects With Metastatic Prostate Cancer
This study is testing a new treatment called ARX517 for men with metastatic prostate cancer to see if it’s safe and how well it works, both on its own and with other medications.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 253 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT04662580 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial assesses the safety and tolerability of ARX517, an antibody-drug conjugate, either alone or in combination with androgen receptor pathway inhibitors in adult patients with metastatic prostate cancer. The study is designed as a multicenter, open-label, dose-escalation and dose-expansion trial, focusing on pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Participants will be closely monitored for adverse effects and treatment responses to determine the optimal dosing and effectiveness of the therapy.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed prostate adenocarcinoma and documented disease progression after prior treatments.
Not a fit: Patients who do not have PSMA-positive metastatic lesions or those who have not received prior treatments as specified in the protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic prostate cancer, potentially improving outcomes and quality of life.
How similar studies have performed: Other studies involving antibody-drug conjugates for prostate cancer have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Male and ≥18 years at the time of providing written informed consent. * Histologically confirmed prostate adenocarcinoma. * For subjects who have not undergone an orchiectomy, must be undergoing treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist and must agree to continue such therapy while on study treatment. Subjects enrolled to mCRPC cohorts must have serum testosterone levels of ≤50ng/dL (1.73nM at Screening). * Must receive prior treatment(s) as defined in the protocol for each cohort * Documented evidence of disease progression on or after the most-recent prior regimen for mCRPC cohorts * mCSPC combination cohorts: High volume metastatic disease documented by CT/MRI and/or 99mTC bone scan (for bone lesions) * Adequate blood counts * Must have at least 1 PSMA-positive metastatic lesion and no measurable PSMA-negative lesions by local assessment for alternative dosing regimen and combination cohorts. Key Exclusion Criteria * Receipt of chemotherapy within 21 days prior to enrollment; hormonal therapy (not including LHRH analogs) within 7 days prior to enrollment; palliative radiation therapy within 7 days prior to enrollment; or any other anticancer therapy within 21 days prior to enrollment or other therapy for monotherapy cohorts * Receipt of more than 1 prior taxane regimen or non-taxane chemotherapy for prostate cancer for alternative dose regimen and mCRPC combination cohorts * Receipt prior apalutamide, enzalutamide, or darolutamide, or AAP for mCRPC combination cohorts * Receipt any prior chemotherapy or prior ARPI, and must be greater than 90 days of ADT prior to enrollment for mCSPC combination cohorts * Use of chronic systemic glucocorticoids equivalent to \> 10 mg prednisone daily. Note: short-term administration of systemic corticosteroids \> 10 mg prednisone equivalent (e.g., for allergic reactions or management of immune- or infusion-related AEs) is allowed. * Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with asymptomatic, untreated CNS metastases are eligible provided they have been clinically stable (neurologically stable and not requiring steroids for at least 28 days prior to enrollment). * History of any invasive malignancy (other than primary) within the previous 2 years prior to the enrollment date that requires active therapy or is at high risk of recurrence in the opinion of the investigator. * Marked baseline prolongation of QT/QT interval corrected for heart rate (QTc), e.g., a triplicate-average QTc interval \> 480 milliseconds (CTCAE Grade 2) using Fridericia's QT correction formula at any time within 28 days before enrollment, ongoing history of CTCAE Grade ≥2 QTc at enrollment, or anticipated need to perform repeat ECG evaluations to satisfy re-treatment criteria. * Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months prior to enrollment date. * Clinically significant ocular findings by a qualified ophthalmologist or optometrist including active ocular infections or chronic corneal disorders unless approved by the Medical Monitor. * Peripheral neuropathy Grade ≥ 2 within 28 days prior to enrollment. * For combination cohorts with apalutamide: no prior history of seizure or condition that may predispose to seizure (including but not limited to prior cerebrovascular accident, TIA or loss of consciousness within the last 12 months, brain AVM, brain metastases). * 24-hour urine protein \> 1g/24h
Where this trial is running
Los Angeles, California and 8 other locations
- University of California, Los Angeles School of Medicine — Los Angeles, California, United States (Recruiting)
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (Recruiting)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (Recruiting)
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
- Washington University St. Louis School Medicine Siteman Cancer Center — Saint Louis, Missouri, United States (Recruiting)
- GU Research Network — Omaha, Nebraska, United States (Recruiting)
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.