A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
1 other identifier
interventional
100
1 country
2
Brief Summary
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Sep 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 31, 2025
November 1, 2025
1.7 years
August 21, 2024
December 26, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Recommended phase II dose (Phase Ib)
21 or 28 days
Incidence and severity of adverse events (AE) (Phase Ib)
2 years
PSA response rate (Phase II)
1 year
Secondary Outcomes (11)
Objective response rate (ORR)
1 year
Disease control rate (DCR)
1 year
Duration of response (DoR)
1 year
PSA response rate
1 year
Time to PSA progression
1 year
- +6 more secondary outcomes
Study Arms (4)
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
EXPERIMENTALHRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
EXPERIMENTALHRS-5041 tablets combined with HRS-1167 tablets
EXPERIMENTALHRS-5041 tablets combined with SHR2554 tablets
EXPERIMENTALInterventions
HRS-5041 tablets
Abiraterone Acetate tablets（II）
Prednisone Acetate tablets
Docetaxel Injection
Eligibility Criteria
You may qualify if:
- Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements.
- The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male.
- ECOG score is 0 or 1.
- An expected survival of ≥ 12 weeks.
- Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma.
- Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples.
- Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 3 months after the last dose of the investigational drug.
You may not qualify if:
- Plan to receive any other antitumor therapy during this study.
- Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose.
- Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter.
- Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures.
- Drugs with a strong inducer or inhibitor of the metabolic enzyme CYP3A have been used in the past, and the washout period from the end time to the first administration in this study is shorter than the 5 half-life of the drug.
- The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
- Central nervous system or meningeal metastasis of tumors is known or subjects have a history of primary central nervous system tumors.
- Severe cerebrovascular disease occurred within 6 months prior to administration.
- Subjects with poorly controlled hypertension and a history of hypertensive crisis or hypertensive encephalopathy.
- Severe bone injury due to bone metastases, pathological fractures , and spinal cord compression as determined by the investigators at important sites that occurred within the last 6 months or are expected to occur in the near future.
- Having one of multiple factors that affect the oral drug or having an active gastrointestinal disease or other disease that may significantly affect drug absorption, distribution, metabolism, or excretion.
- Had history of allergy to the proposed investigational drug or its excipient components.
- Presence of active heart disease in the 6 months prior to first dosing, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias.
- Presence of active hepatitis B and hepatitis C; Or serious infected persons requiring antibiotics, antivirals or antifungal drugs to control.
- Presence of the history of immunodeficiency or organ transplantation.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 23, 2024
Study Start
September 25, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
December 31, 2025
Record last verified: 2025-11