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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
3/07/2025
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
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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
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Secondary ID [1]
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HRS-5041-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.
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Timepoint [1]
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Screening up to study completion, an average of 1 year.
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Secondary outcome [1]
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Concentration
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Assessment method [1]
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Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data
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Timepoint [1]
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Screening up to study completion,an average of 1 year.
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Secondary outcome [2]
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Cmax,ss
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Assessment method [2]
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Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.
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Timepoint [2]
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From administration to C2, up to 4 months.
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Secondary outcome [3]
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Cmin,ss
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Assessment method [3]
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Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data
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Timepoint [3]
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From administration to C2, up to 4 months.
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Secondary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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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.
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Timepoint [4]
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Screening up to study completion, an average of 2 years.
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Secondary outcome [5]
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Best of Response (DoR)
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Assessment method [5]
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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).
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Timepoint [5]
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Screening up to study completion, an average of 2 years.
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Secondary outcome [6]
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Disease Control Rate (DCR)
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Assessment method [6]
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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.
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Timepoint [6]
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Screening up to study completion, an average of 2 years.
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Secondary outcome [7]
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rPFS (radiographic progression-free survival
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Assessment method [7]
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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.
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Timepoint [7]
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Screening up to study completion, an average of 2 years.
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Secondary outcome [8]
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PSA Response Rate at the end of Week 12
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Assessment method [8]
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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.
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Timepoint [8]
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Screening up to the end of Week 12 , up to 4 months.
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Secondary outcome [9]
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Proportion of Subjects with PSA50 (= 50% decline in serum PSA from baseline)
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Assessment method [9]
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Refers to proportion of subjects with a =50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.
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Timepoint [9]
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Screening up to the end of treatment, an average of 1 year.
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Secondary outcome [10]
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Proportion of Subjects with PSA30 (= 30% decline in serum PSA from baseline)
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Assessment method [10]
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Refers to proportion of subjects with a =30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.
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Timepoint [10]
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Screening up to the end of treatment, an average of 1 year.
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Secondary outcome [11]
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Time to PSA Progression
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Assessment method [11]
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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.
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Timepoint [11]
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From the date of first drug administration to the date of first PSA progression, an average of 1 year.
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Secondary outcome [12]
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Overall Survival (OS)
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Assessment method [12]
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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.
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Timepoint [12]
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From the date of first drug administration to the date of death from any cause, an average of 2 year.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/03/2027
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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GenesisCare North Shore (Oncology) - Sydney
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Recruitment hospital [2]
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Sydney Adventist Hospital - Sydney
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Recruitment hospital [3]
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Cancer Research SA - Adelaide
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Recruitment hospital [4]
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Southern Oncology Clinical Research Unit - Adelaide
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Recruitment hospital [5]
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Icon Cancer Centre South Brisbane - Brisbane
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Recruitment hospital [6]
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John Flynn Private Hospital - Brisbane
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Recruitment hospital [7]
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Eastern Health (Box Hill Hospital) - Melbourne
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Recruitment hospital [8]
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Linear Clinical Research Ltd - Perth
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Recruitment hospital [9]
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Macquarie University - Sydney
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Recruitment hospital [10]
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MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy - Sydney
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Recruitment hospital [11]
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Illawarra Shoalhaven Local Health District (Wollongong Hospital) - Wollongong
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Melbourne
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Recruitment postcode(s) [5]
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- Perth
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Recruitment postcode(s) [6]
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- Wollongong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Atridia Pty Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
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Trial website
https://clinicaltrials.gov/study/NCT06830850
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kathy You
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Address
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Country
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Phone
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+61 02 9299 0433
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Fax
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Email
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[email protected]
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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
Download to PDF