SHR-6914 in adults with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SHR-6914 as monotherapy in adults with metastatic prostate cancer. Eligible participants have histologically confirmed prostate adenocarcinoma with metastatic disease, good performance status, and adequate organ function. The trial will monitor safety and PK signals to determine how the drug behaves in the body and whether there are signs of clinical activity. Participants with untreated CNS disease or recent other cancers are excluded, as are those with uncontrolled tumor-related pain or severe cardiovascular conditions. The study is led by Suzhou Suncadia Biopharmaceuticals with Sun Yat-sen University Cancer Center as the participating site.

Why it matters

Who can join: the full rules

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

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yue Cheng
• Email: yue.cheng.yc50@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.