This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.
Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
Presence of metastatic lesions confirmed by evaluable imaging examinations (per PCWG4, evaluable imaging examinations refer to examinations with definite lesion assessment criteria, including CT, MRI or bone scan).
Has an ECOG PS 0-1.
Has a life expectancy of ≥ 3 months.
With untreated local therapy (radiotherapy or surgery) or active central nervous system (CNS) tumor metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis.
Patients with other malignant tumors within 5 years prior to the first study drug administration, excluding adequately treated basal cell carcinoma or squamous cell carcinoma.
Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.
Having severe cardiovascular and cerebrovascular diseases
Single group
SHR-6914
DrugSHR-6914
Incidence of dose-limiting toxicity (DLT)
Incidence and severity of adverse events (AEs)
Serious adverse events (SAEs) .
MTD
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