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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