HRS-5041 for Metastatic Castration-resistant Prostate Cancer
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
Phase 1Interventional Study
Metastatic Castration Resistant Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Atridia Pty Ltd. · Industry
Who this trial is looking for
This trial is looking for men with metastatic castration-resistant prostate cancer to test the safety and effectiveness of a new treatment called HRS-5041. Participants will need to be healthy enough to take part and must not be undergoing other cancer treatments during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I understand the trial procedures and possible side effects.
I have good bone marrow and organ function.
I have metastatic castration-resistant prostate cancer.
You may not be able to join if
I plan to receive any other cancer treatments during the study.
I have had any chemotherapy or surgery in the last 4 weeks.
I have uncontrolled high blood pressure.
I have trouble swallowing or severe gastrointestinal problems.
I have a history of severe allergies.
I have active heart disease in the last 6 months.
I have had another cancer in the last 5 years.
I have a positive test for hepatitis B, hepatitis C, or syphilis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Trial Locations
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Eligibility Criteria
IInclusion Criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
2. Adequate bone marrow and other vital organ functions
3. Adequate liver function tests
4. Metastatic Castration-resistant Prostate Cancer
Exclusion Criteria
1. Pl…
IInclusion Criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
2. Adequate bone marrow and other vital organ functions
3. Adequate liver function tests
4. Metastatic Castration-resistant Prostate Cancer
Exclusion Criteria
1. Plan to receive any other anti-tumor therapy during the study.
2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
3. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy).
4. 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.
5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
6. Active heart disease within 6 months prior to the first dosing of this study.
7. Medical history of other malignant tumor within 5 years prior to dosing.
8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
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