A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
The purpose of this study is to evaluate the safety and tolerability of HRS-7525 in participants with Advanced Prostate Cancer, and to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD, if possible), and the recommended Phase II dose (RP2D) of HRS-7525.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participating in this clinical study, understanding the study procedures, and being able to provide written informed consent;
Males, aged 18-80 years (inclusive; no upper age limit in the expansion stage);
Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;
Life expectancy ≥12 weeks;
Disqualifiers
Planning to receive any other anti-tumor therapy during this study;
Having received chemotherapy, targeted therapy, immunotherapy, live attenuated vaccines, radiotherapy, or surgery, etc., less than 4 weeks prior to the start of study treatment; participating in another clinical study within 4 weeks prior to the start of study treatment (calculated from the last use of the investigational drug);
Damage caused by any prior anti-tumor treatment has not recovered to Grade ≤ 1 or the criteria specified in this study (graded according to NCI-CTCAE 6.0; excluding alopecia and other adverse events deemed tolerable by the investigator);
Participants with poorly controlled hypertension, and those with a history of hypertensive crisis or hypertensive encephalopathy;
Trial design
Design model
Single group
Treatments tested in this trial
HRS-7525 tablets
DrugHRS-7525 tablets
Treatment groups
320 Participants
are divided into 1 treatment groupGroup A: HRS-7525 tabletsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
dose limiting toxicity (DLT)
Time frame
a single-dose run-in period (2 days) and 21 days after the first administration of each subject2
the maximum tolerated dose (MTD)
Time frame
From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 months3
the recommended Phase II dose (RP2D)
Time frame
From the signing of the informed consent to the end of the safety follow-up period of each subject ，about 13 monthsSponsors and contacts
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Source ClinicalTrials.gov