NCT07735377RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- 26 Aug 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07735377
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 118
- From 26 Aug 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.