A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAtridia Pty Ltd.

About this trial

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.

Eligibility criteria

Qualifiers

Adequate bone marrow and other vital organ functions

Adequate liver function tests

Metastatic Castration-resistant Prostate Cancer

Disqualifiers

Plan to receive any other anti-tumor therapy during the study.

Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.

Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).

Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.

Trial design

Treatments tested in this trial

  • HRS-5041 Single dose of HRS-5041 orally administered

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators