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

Progenics Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: PSMA ADC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01695044

PSMA ADC 2301

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A diagnosis of metastatic castration-resistant prostate cancer.

2. 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.

3. 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.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

5. Life expectancy ≥ six months.

6. 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.

Exclusion criteria

1. 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

2. Clinically significant cardiac disease or severe debilitating pulmonary disease

3. An acute infection requiring ongoing antibiotic therapy

4. 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.

5. History of drug and/or alcohol abuse

6. History of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Arm 1: PSMA ADC

Experimental group

Description:

Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

Treatment:

Drug: PSMA ADC