Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517, with Randomized Comparison to Investigator's Choice of Treatment (ICT), in Subjects with Metastatic Castration-resistant Prostate Cancer who are Resistant or Refractory to Prior Standard Therapies

Official Title

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of ARX517, With Randomized Comparison to Investigator's Choice of Treatment, in Subjects With Metastatic Castration-resistant Prostate Cancer Who Are Resistant or Refractory to Prior Standard Therapies

Details

This is a first-in-human, Phase 1/2, multicenter, open-label study to evaluate the safety, PK, PDy, and preliminary anti-tumor activity of ARX517 in subjects with mCRPC who are resistant or refractory to standard therapies. Phase 1a and 1b dose-escalation and dose expansion stages will identify the MTD and/or RP2D(s). Phase 2 will randomize subjects to receive ARX517 at the RP2D(s) or ICT as comparator. The ICT to be used in Phase 2 will be determined after reviewing all available clinical data in Phase 1

Keywords

Prostate Cancer, ADC, Antibody drug conjugate, Prostate neoplasma, Castration-resistant, PSA increased, PSMA, Prostate specific membrane antigen, PSMA ADC, Prostatic Neoplasms, ARX517

Eligibility

You can join if…

Open to males ages 18 years and up

  • Male subjects ≥ 18 years at the first time of providing written informed consent.
  • Histologically confirmed prostate adenocarcinoma.
  • Documented metastatic disease.
  • Castration-resistant prostate cancer per the Prostate Cancer Working Group 3 (PCWG3).
  • 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.
  • Prior treatment with at least two FDA-approved therapies for metastatic prostate cancer with at least one being an androgen receptor signaling inhibitor
  • Adequate blood counts

You CAN'T join if...

  • Have central nervous system (CNS) metastasis, unless the CNS metastasis was treated with local therapy and has proven to be stable over the last 2 months prior to the enrollment date, and not currently requiring ongoing systemic steroid treatment
  • History of any invasive malignancy (other than primary) within previous 2 years prior to the enrollment date that requires active therapy
  • 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.
  • 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

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of California Los Angeles School of Medicine accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ambrx, Inc.
ID
NCT04662580
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated