Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Incidence of Adverse Events (AEs)

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

The Incidence of Adverse Events is defined as the proportion of subjects in a clinical trial who experience at least one Adverse Event (AE) during the defined observation period, which is assessed by CTCAE 5.0.

PSA Response Rate

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

Disease control rate (DCR)

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

Defined as the proportion of subjects whose best overall response, assessed per RECIST 1.1 and PCWG3, is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) .

Radiographic Progression-Free Survival (rPFS)

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

Defined as the time from treatment initiation to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first.

Time to First Skeletal-Related Event (SRE)

Time frame · From baseline to primary completion, which may take up to 24 to 48 weeks

Defined as the interval from the date of treatment initiation to the date of the first occurrence of any of the following clinically significant events attributable to bone metastasis: pathological fracture (vertebral or non-vertebral), palliative radiation therapy to bone for pain relief, surgical intervention to bone to prevent or treat a fracture or spinal cord compression, or confirmed spinal cord compression.