A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.

Eligibility criteria

Qualifiers

Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements.

The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male.

ECOG score is 0 or 1.

An expected survival of ≥ 12 weeks.

Disqualifiers

Plan to receive any other antitumor therapy during this study.

Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose.

Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter.

Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures.

Trial design

Treatments tested in this trial

  • HRS-5041 tablets
  • Abiraterone Acetate tablets(II)
  • Prednisone Acetate tablets
  • Docetaxel Injection
  • HRS-1167 tablets
  • SHR2554 tablets
  • HRS-6208 capsules
  • Darolutamide Tablets

Treatment groups

100 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.