DEC003M in Prostate Cancer

Inclusion criteria

• At the time of informed consent, be ≥18 years of age.
• Histologically confirmed adenocarcinoma of the prostate.
• Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.
• Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .
• Measurable disease prior to enrollment.
• Testosterone at castration level.
• Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.
• At least 1 prior Androgen Receptor Pathway Inhibitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

• History of other malignancies.
• Inadequate organ function.
• Active autoimmune disease.
• Active CNS involvement.
• Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
• Any prior medical history of ILD/pneumonitis.
• Clinically significant corneal disorder or known severe dry eye.
• Grade 2 or higher peripheral neuropathy.
• Inadequate washout period for prior anticancer treatment.
• Any known history of or suspicion for history of clinically significant liver disease .
• Known hypersensitivity to any component of the DEC003M.
• Prior treatment with a PSMA-targeted antibody therapy.
• Other conditions judged by the investigator that may have effects on the patient's participation in the study.