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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: PSMA ADC

• Registration Number: NCT01414283
• Lead Sponsor: Progenics Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2013-04
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	PSMA ADC	-

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose of PSMA ADC	13 weeks

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States