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

Starting soon · Phase 1

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID: NCT07735377
Run by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
People needed: 118
Starts: 2026-08-01
Expected to finish: 2028-08-01
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.
Has adequate organ function

You may not qualify if…

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
Suffering from active severe digestive system diseases
History of prior interstitial pneumonia
Has active infection requiring systemic treatment.
Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1

Where it is running

Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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