NCT02020135

An Open-label Extension Study of PSMA ADC 2301 in mCRPC

An Open-label Treatment Extension of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Progenics Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC 2301 extension study. Subjects who are benefiting from treatment may be able to receive up to an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	PSMA ADC	Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2013-12-24
• Last updated: 2017-03-24
• Results posted: 2017-02-23

Locations

6 sites across 1 country: United States