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
Recruiting · NCT06830850 · Interventional (participants receive a specific treatment) · Lead sponsor: Atridia Pty Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HRS-5041 Single dose of HRS-5041 orally administered
What this trial is about
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 criteria
- 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 it is running
11 locations listed.
- 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
- Macquarie University - Sydney, Australia
- MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy - Sydney, Australia
- Illawarra Shoalhaven Local Health District (Wollongong Hospital) - Wollongong, Australia
- GenesisCare North Shore (Oncology) - Sydney, New South Wales, Australia
- Sydney Adventist Hospital - Sydney, New South Wales, Australia
- Cancer Research SA - Adelaide, South Australia, Australia
- Southern Oncology Clinical Research Unit - Adelaide, South Australia, Australia