Tests new drugs with hormone therapy in men with advanced prostate cancer
Tests HS-20093 or SHR2554 with a hormonal drug in adults with prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
Key facts
- Where
- Nanjing and Tianjin, ChinaSee the 2 sites
- Phase
- Phase 2
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: NCT07230106, who can take part
Where in China
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Tianjin Medical University Cancer Institute and HospitalTianjin, 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
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT07230106
- Record updated
- 3 March 2026
- Original description
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.Read full original descriptionShow less
A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
Inclusion: Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent; Aged 18 to 80 years (inclusive), male; ECOG performance status of 0 or 1; Expected survival time ≥12 weeks; Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma; Able to provide sufficient tumor tissue samples for retrospective genetic testing; Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration); PSA level ≥1 ng/ml at screening; Adequate organ function levels at baseline assessment; Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.
Exclusion: Known hypersensitivity or intolerance to the investigational drug(s) or their excipients; Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0; Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment; Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment; Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment; Serious active infections within 14 days prior to enrollment; Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease; Dysphagia or other conditions significantly affecting drug absorption; Severe cardiovascular or cerebrovascular diseases; Moderate to severe pulmonary disease significantly affecting respiratory function; Poorly controlled diabetes; Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases; History of other malignancies within 5 years prior to enrollment; Any other condition deemed by the investigator to potentially affect the study; Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months; Poorly controlled tumor-related pain; Known central nervous system metastases or primary brain tumors; Significant pericardial, pleural, or peritoneal effusion requiring intervention.