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
NCT ID: NCT06830850
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2025-06-15
2027-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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: HRS-5041 dose level 1
240 mg BID
HRS-5041 Single dose of HRS-5041 orally administered
HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
Interventions
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HRS-5041 Single dose of HRS-5041 orally administered
HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
Eligibility Criteria
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Inclusion Criteria
2. Adequate bone marrow and other vital organ functions
3. Adequate liver function tests
4. Metastatic Castration-resistant Prostate Cancer
Exclusion Criteria
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.
18 Years
MALE
No
Sponsors
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Atridia Pty Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Facility Contacts
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Sarwan Bishnoi
Role: primary
Jane Stidworthy
Role: primary
Other Identifiers
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HRS-5041-103
Identifier Type: -
Identifier Source: org_study_id
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