A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HS-20093 for Injection
- SHR3680 Tablet
- Abiraterone Tablet
- SHR2554 Tablet
- Enzalutamide Tablet
- Darotamine Capsule
Treatment groups
218 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov