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
About this study
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
- Condition
- Metastatic Castration Resistant Prostate Cancer
- Tested
- HRS-5041 Single dose of HRS-5041 orally administered
- Sponsor
- Atridia Pty Ltd.
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Metastatic Castration Resistant Prostate Cancer
- IInclusion Criteria
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- Metastatic Castration-resistant Prostate Cancer
Exclusion 8
- 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.
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- Active heart disease within 6 months prior to the first dosing of this study.
- Medical history of other malignant tumor within 5 years prior to dosing.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Where
11 sites, 11 recruiting
Cancer Research SA
Adelaide, South Australia, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Icon Cancer Centre South Brisbane
Brisbane, Australia
John Flynn Private Hospital
Brisbane, Australia
Eastern Health (Box Hill Hospital)
Melbourne, Australia
Linear Clinical Research Ltd
Perth, Australia
and 5 more sites on ClinicalTrials.gov
Contact
-
Kathy You
+61 02 9299 0433 kathyyou@atridia.com
-
Ravi Patel
+61 452 363 506 ravi.patel@atridia.com
Potential match only. Final eligibility is determined by the study team.