Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
HRS-5041-103
Clinical summary
Summary
This study aims to assess the safety and tolerability of HRS-5041, as well as how it is processed in the body, in people with metastatic castration-resistant prostate cancer (mCRPC).
Researchers will also evaluate the drug's preliminary effects on tumour response, disease progression and PSA levels.
Eligible participants will receive HRS-5041 tablets twice daily in 28-day treatment cycles.
To be eligible, participants must not have received chemotherapy, targeted therapy, immunotherapy, radiotherapy, live or attenuated vaccines, or undergone surgery within 4 weeks before the first study dose.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer.
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Atridia Pty Ltd.
Scientific Title
A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
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