A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: PSMA ADC
Intervention description: PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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