A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-6914 Injection in Participants With Prostate Cancer

Summary

This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
2. 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).
3. Has an ECOG PS 0-1.
4. Has a life expectancy of ≥ 3 months.
5. Has adequate organ function

Exclusion Criteria:

1. 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.
2. 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.
3. Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.
4. Having severe cardiovascular and cerebrovascular diseases
5. Suffering from active severe digestive system diseases
6. History of prior interstitial pneumonia
7. Has active infection requiring systemic treatment.
8. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1

Conditions2

Interventions1

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