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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06830850




Registration number
NCT06830850
Ethics application status
Date submitted
12/02/2025
Date registered
17/02/2025
Date last updated
28/02/2025

Titles & IDs
Public title
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
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
Secondary ID [1] 0 0
HRS-5041-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-5041 Single dose of HRS-5041 orally administered

Experimental: : HRS-5041 dose level 1 - 240 mg BID


Treatment: Drugs: HRS-5041 Single dose of HRS-5041 orally administered
HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination
Timepoint [1] 0 0
Screening up to study completion, an average of 1 year.
Secondary outcome [1] 0 0
Concentration
Timepoint [1] 0 0
Screening up to study completion,an average of 1 year.
Secondary outcome [2] 0 0
Cmax,ss
Timepoint [2] 0 0
From administration to C2, up to 4 months.
Secondary outcome [3] 0 0
Cmin,ss
Timepoint [3] 0 0
From administration to C2, up to 4 months.
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
Screening up to study completion, an average of 2 years.
Secondary outcome [5] 0 0
Best of Response (DoR)
Timepoint [5] 0 0
Screening up to study completion, an average of 2 years.
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
Screening up to study completion, an average of 2 years.
Secondary outcome [7] 0 0
rPFS (radiographic progression-free survival
Timepoint [7] 0 0
Screening up to study completion, an average of 2 years.
Secondary outcome [8] 0 0
PSA Response Rate at the end of Week 12
Timepoint [8] 0 0
Screening up to the end of Week 12 , up to 4 months.
Secondary outcome [9] 0 0
Proportion of Subjects with PSA50 (= 50% decline in serum PSA from baseline)
Timepoint [9] 0 0
Screening up to the end of treatment, an average of 1 year.
Secondary outcome [10] 0 0
Proportion of Subjects with PSA30 (= 30% decline in serum PSA from baseline)
Timepoint [10] 0 0
Screening up to the end of treatment, an average of 1 year.
Secondary outcome [11] 0 0
Time to PSA Progression
Timepoint [11] 0 0
From the date of first drug administration to the date of first PSA progression, an average of 1 year.
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
From the date of first drug administration to the date of death from any cause, an average of 2 year.

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2027
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [2] 0 0
GenesisCare North Shore (Oncology) - Sydney
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [4] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [5] 0 0
Southern Oncology Clinical Research Unit - Adelaide
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06830850