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

PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of PSMA ADC in subjects with metastatic castration-resistant prostate cancer (mCRPC). Subjects must have received 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. 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.

Inclusion Criteria:

1. A diagnosis of metastatic castration-resistant prostate cancer.
2. 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.
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.

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