Prostate Cancer Clinical Trials

• Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.

• Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.

• Presence of disease target or non target lesions (per RECIST v1.1) on CT/MRI and/or presence of disease on full body 99mTc bone scan performed within 28 days of screening.

• Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.

• At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).

• Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).

• Prior major surgery must be at least 12 weeks prior to study entry.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.

• Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.

⁃ Adequate contraception for patients and their partners.

⁃ For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.