Early safety study of SHR-6914 injection in adults with prostate cancer
Tests the safety of SHR-6914 given alone in adults with prostate cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07735377, who can take part
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07735377
- Record updated
- 8 September 2026
- Original description
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.Read full original descriptionShow less
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
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.
Inclusion: 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.
Exclusion: 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; History of prior interstitial pneumonia; Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤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; Having severe cardiovascular and cerebrovascular diseases; Suffering from active severe digestive system diseases; Has active infection requiring systemic treatment.