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Clinical Trials in China / NCT07735377
Recruiting Phase 1

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

NCT07735377 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 1
Started
2026-08-26
Last updated
2026-09-08

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SHR-6914

SHR-6914: SHR-6914

Study 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

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07735377 on ClinicalTrials.gov ↗ ← All trials in China