NCT06783829RecruitingPhase 1
A Study of SHR-4394 Injection in Subjects With Prostate Cancer
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 22 Jan 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT06783829
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 240
- From 22 Jan 2025 to the primary completion date, Mar 2027
- 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
- Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
- Unresolved to CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy;
- Other serious concomitant disease;
- Previous or co-existing malignancies;
Other illness
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
- Active hepatitis B or active hepatitis C;
Other
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Uncontrollable tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
- Other inappropriate situation considered by the investigator.
Who the study is looking for
- Age range: 18-85 years old, male;
- ECOG score for physical condition is 0-1 points;
- Expected survival period ≥ 6 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination;
- Patients with at least one metastasis lesion;
- Disease progression on or after the most-recent prior regimen;
- Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
- Testosterone was at castration level;
- Adequate organ function.
Age in the registry: 18 years to 85 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 |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.