ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
Prostate Cancer
Unknown Primary
ARX517-2011 (primary)
NCI-2021-03637
Summary
This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or
combination therapy in adult subjects with metastatic prostate cancer (mPC).
Objectives
This is a first-in-human (FIH), Phase 1, multicenter, open-label, dose-escalation and
dose-expansion study to evaluate the safety, PK, pharmacodynamic (PDy), and preliminary
anti-tumor activity of ARX517 alone, or in combination with androgen receptor pathway
inhibitors (ARPIs), in adult subjects with metastatic prostate cancer .
Eligibility
- 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
Treatment Sites in Georgia
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