Metastatic Castration Resistant Prostate CancerPhase 1NCT06830850
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
A Phase 1 study testing HRS-5041 Single dose of HRS-5041 orally administered in people with Metastatic Castration Resistant Prostate Cancer, run by Atridia Pty Ltd. at 11 sites in Australia.
Trial summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- HRS-5041 Single dose of HRS-5041 orally administered
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesAustralia
- Study dates
- 15 Jun 2025to 15 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Plan to receive any other anti-tumor therapy during the study.
- Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
- Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).
- 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.
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- Active heart disease within 6 months prior to the first dosing of this study.
- Medical history of other malignant tumor within 5 years prior to dosing.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Australia11 sites
Cancer Research SA
Adelaide, South Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia
Icon Cancer Centre South Brisbane
Brisbane
John Flynn Private Hospital
Brisbane
Eastern Health (Box Hill Hospital)
Melbourne
Linear Clinical Research Ltd
Perth
GenesisCare North Shore (Oncology)
Sydney, New South Wales
Sydney Adventist Hospital
Sydney, New South Wales
Macquarie University
Sydney
MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy
Sydney
Illawarra Shoalhaven Local Health District (Wollongong Hospital)
Wollongong
About this study
Official 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
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
- Being tested
- HRS-5041 Single dose of HRS-5041 orally administered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5041 Single dose of HRS-5041 orally administeredDrug
HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| : HRS-5041 dose level 1 | Experimental | 240 mg BID Receives: Drug: HRS-5041 Single dose of HRS-5041 orally administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
Measured: Screening up to study completion, an average of 1 year.
Secondary outcomes (12)
Concentration
Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data
Measured: Screening up to study completion,an average of 1 year.
Cmax,ss
Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.
Measured: From administration to C2, up to 4 months.
Cmin,ss
Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data
Measured: From administration to C2, up to 4 months.
Objective Response Rate (ORR)
ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline.
Measured: Screening up to study completion, an average of 2 years.
Best of Response (DoR)
Best of Response (DoR) BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).
Measured: Screening up to study completion, an average of 2 years.
Disease Control Rate (DCR)
Disease Control Rate (DCR) DCR refers to the time from the first occurrence of CR or PR to PD or death from any cause, whichever occurs first, in subjects with objective response. For subjects who have a confirmed CR or PR, DoR is calculated as the time from the date of first assessment confirming CR or PR to the date of first recorded radiographic disease progression or death from any cause, whichever occurs first. If the subject does not experience PD or death or is lost to follow-up at the end of study, DoR will be censored at the time of the last tumor evaluation.
Measured: Screening up to study completion, an average of 2 years.
rPFS (radiographic progression-free survival
rPFS refers to the time from the first dose of investigational drug to the first radiographic PD or death from any cause (whichever occurs first) as assessed by the investigator. Radiographic disease progression includes both bone progression (based on PCWG3 criteria) and soft tissue progression (based on RECIST v1.1 criteria), with either type of progression counting as progression.
Measured: Screening up to study completion, an average of 2 years.
PSA Response Rate at the end of Week 12
Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) at the end of 12 weeks of study treatment.
Measured: Screening up to the end of Week 12 , up to 4 months.
Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)
Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.
Measured: Screening up to the end of treatment, an average of 1 year.
Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)
Refers to proportion of subjects with a ≥30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.
Measured: Screening up to the end of treatment, an average of 1 year.
Time to PSA Progression
Refers to time from the date of first drug administration to the date of first PSA progression. PSA progression is determined based on PCWG3 criteria.
Measured: From the date of first drug administration to the date of first PSA progression, an average of 1 year.
Overall Survival (OS)
OS refers to the time from the date of first drug administration to the date of death from any cause. From the date of first drug administration to the date of death from any cause.
Measured: From the date of first drug administration to the date of death from any cause, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830850
- Sponsor's protocol ID
- HRS-5041-103
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06830850
- Acronym / sponsor ID
- HRS-5041-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| : HRS-5041 dose level 1 | Experimental | Drug: HRS-5041 Single dose of HRS-5041 orally administered240 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Plan to receive any other anti-tumor therapy during the study.
- Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
- Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).
- 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.
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-5041 Single dose of HRS-5041 orally administeredHRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle. | Drug | : HRS-5041 dose level 1 |
Primary outcome
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
Time frame: Screening up to study completion, an average of 1 year.
To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
12 secondary outcomes
Concentration
Time frame: Screening up to study completion,an average of 1 year.
Cmax,ss
Time frame: From administration to C2, up to 4 months.
Cmin,ss
Time frame: From administration to C2, up to 4 months.
Objective Response Rate (ORR)
Time frame: Screening up to study completion, an average of 2 years.
Best of Response (DoR)
Time frame: Screening up to study completion, an average of 2 years.
Disease Control Rate (DCR)
Time frame: Screening up to study completion, an average of 2 years.
rPFS (radiographic progression-free survival
Time frame: Screening up to study completion, an average of 2 years.
PSA Response Rate at the end of Week 12
Time frame: Screening up to the end of Week 12 , up to 4 months.
Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)
Time frame: Screening up to the end of treatment, an average of 1 year.
Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)
Time frame: Screening up to the end of treatment, an average of 1 year.
Time to PSA Progression
Time frame: From the date of first drug administration to the date of first PSA progression, an average of 1 year.
Overall Survival (OS)
Time frame: From the date of first drug administration to the date of death from any cause, an average of 2 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-5041 Single dose of HRS-5041 orally administered in people with Metastatic Castration Resistant Prostate Cancer, run by Atridia Pty Ltd. at 11 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Screening up to study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.