Study of HRS-2189 Combined HRS-5041 in Prostate Cancer
ConditionProstate Cancer Metastatic Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFudan University
About this trial
Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic prostate cancer.
Eligibility criteria
Qualifiers
18 years to 80 years old (including boundary values), male subjects;
ECOG PS Score: 0~1;
Histologically or cytologically confirmed prostate adenocarcinoma, and no prior diagnosed as neuroendocrine carcinoma or small cell carcinoma;
Disease progression when enrolled in the study;
Disqualifiers
Known existence of CNS metastasis or meningeal metastasis, or known history of primary CNS tumor;
Severe bone injury caused by bone metastasis identified by investigators, including uncontrolled severe bone pain, pathological bone fracture at the important part and spinal cord compression having occurred for the last 6 months or expected to occur in the near future;
Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy or attenuated live vaccine within 4 weeks before first dose of study therapy (6-week washout period for bicalutamide);
Trial design
Treatments tested in this trial
- HRS-2189
- HRS-5041
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov