Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Typical duration for phase_1
1 active site
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
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 12, 2023
CompletedStudy Start
First participant enrolled
August 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedFebruary 19, 2025
February 1, 2025
2.1 years
July 5, 2023
February 15, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Dose-limiting toxicity (DLT)
Up to 28 days
Maximum tolerated dose (MTD)
Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041
Up to 28 days
Secondary Outcomes (9)
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
Pharmacokinetics - Area under the plasma concentration time curve (AUC)
12 weeks
Pharmacokinetics - Maximum plasma concentration (Cmax)
12 weeks
Pharmacokinetics - Time to Cmax (Tmax)
12 weeks
Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
24 months
- +4 more secondary outcomes
Study Arms (1)
HRS-5041
EXPERIMENTALInterventions
HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.
Eligibility Criteria
You may qualify if:
- Able and willing to provide a written informed consent.
- Age 18-80 years old, gender unlimited.
- The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1.
- Predicted survival ≥12 weeks.
- Histological or cytological confirmed adenocarcinoma of the prostate.
- Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.
You may not qualify if:
- Prior treatment with an androgen receptor (AR) degrader.
- Plan to receive any other antitumor therapy during this trial.
- Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.
- Patients with known brain metastases.
- Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2023
First Posted
July 12, 2023
Study Start
August 3, 2023
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
February 19, 2025
Record last verified: 2025-02