Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Overview

Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.

Full Title of Study: “A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: PSMA ADC
    • PSMA ADC administered IV

Arms, Groups and Cohorts

  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

  • Determine the maximum tolerated dose of PSMA ADC
    • Time Frame: 13 weeks

Participating in This Clinical Trial

Inclusion Criteria

1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer. 2. Prior chemotherapy regimens, one of which contains taxane. 3. Eastern Cooperative Oncology Group status of 0 or 1 Exclusion Criteria:

1. Clinically significant cardiac disease or severe debilitation pulmonary disease 2. Evidence of an active infection requiring ongoing antibiotic therapy 3. Any prior treatment with any other therapy targeting PSMA 4. History of drug and/or alcohol abuse

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Progenics Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert J Israel, MD, Study Director, Progenics Pharmaceuticals, Inc.

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