A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.

Key facts

Study ID

NCT01695044

Run by

Progenics Pharmaceuticals, Inc.

People needed

119

Starts

2012-09-01

Expected to finish

2015-02-01

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…

• A diagnosis of metastatic castration-resistant prostate cancer.
• a) 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.
• OR
• b) No prior history of treatment with a cytotoxic chemotherapy regimen.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Life expectancy ≥ six months.
• Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.

You may not qualify if…

• 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
• Clinically significant cardiac disease or severe debilitating pulmonary disease
• An acute infection requiring ongoing antibiotic therapy
• 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.
• History of drug and/or alcohol abuse
• History of pancreatitis

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Burbank, California, United States
• Study site — Encinitas, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Fairway, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Rockville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Lake Success, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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