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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02020135

Run by

Progenics Pharmaceuticals, Inc.

People needed

9

Starts

2013-10-01

Expected to finish

2015-03-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have completed the PSMA ADC 2301 study and who, in the opinion of the investigator, are likely to benefit from continued treatment with PSMA ADC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• If chemically castrated, subjects must agree to stay on androgen-deprivation therapy for the duration of the study
• If applicable, men must agree to commit to the use of a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug

You may not qualify if…

• An acute infection requiring ongoing antibiotic therapy (e.g., UTI, indwelling catheter or other potential site(s) of infection)
• History of significant hypersensitivity reactions to PSMA ADC or any of its components, or to any prior investigational or approved monoclonal antibodies (mAbs), immunoglobulin (Ig) fusion proteins (e.g., circulating neutralizing antibodies), or ADC
• Clinically significant cardiac disease or severe debilitating pulmonary disease
• Any recent or ongoing medical condition that may interfere with a subject's participation or compliance with the study or evaluation of PSMA ADC

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Stony Brook, New York, United States
• Study site — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.