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A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria:

1. A diagnosis of metastatic castration-resistant prostate cancer.

2. Prior history of treatment with at least one taxane-containing chemotherapy regimen
(e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic
chemotherapy regimens, Sponsor approval is required for study participation.

3. Must have received and progressed on abiraterone acetate and/or enzalutamide. If
subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor
approval is required for participation in the study.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

5. Life expectancy ≥ six months.

Exclusion Criteria:

1. Treatment within 30 days prior to first dose of study drug of the following:

- External Radiation therapy

- Radiopharmaceuticals

- Cytotoxic chemotherapy

- Treatment with an investigational agent

2. Clinically significant cardiac disease or severe debilitating pulmonary disease

3. An acute infection requiring ongoing antibiotic therapy

4. Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other
antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE)
(e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved
by Sponsor.

5. History of drug and/or alcohol abuse

6. History of pancreatitis

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-tumor response

Outcome Description:

Changes in tumor assessments (RECIST 1.1 criteria), changes in serum PSA and circulating tumor cells

Outcome Time Frame:

25 weeks

Safety Issue:


Principal Investigator

Robert J Israel, MD

Investigator Role:

Study Director

Investigator Affiliation:

Progenics Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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