Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-01 @ 12:14 PM
Study NCT ID:
NCT06830850
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Screening up to study completion, an average of 1 year.', 'description': 'To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.'}], 'secondaryOutcomes': [{'measure': 'Concentration', 'timeFrame': 'Screening up to study completion,an average of 1 year.', 'description': 'Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data'}, {'measure': 'Cmax,ss', 'timeFrame': 'From administration to C2, up to 4 months.', 'description': 'Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.'}, {'measure': 'Cmin,ss', 'timeFrame': 'From administration to C2, up to 4 months.', 'description': 'Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Screening up to study completion, an average of 2 years.', 'description': '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.'}, {'measure': 'Best of Response (DoR)', 'timeFrame': 'Screening up to study completion, an average of 2 years.', 'description': '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).'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Screening up to study completion, an average of 2 years.', 'description': '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.'}, {'measure': 'rPFS (radiographic progression-free survival', 'timeFrame': 'Screening up to study completion, an average of 2 years.', 'description': '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.'}, {'measure': 'PSA Response Rate at the end of Week 12', 'timeFrame': 'Screening up to the end of Week 12 , up to 4 months.', 'description': '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.'}, {'measure': 'Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)', 'timeFrame': 'Screening up to the end of treatment, an average of 1 year.', 'description': 'Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.'}, {'measure': 'Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)', 'timeFrame': 'Screening up to the end of treatment, an average of 1 year.', 'description': 'Refers to proportion of subjects with a ≥30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.'}, {'measure': 'Time to PSA Progression', 'timeFrame': 'From the date of first drug administration to the date of first PSA progression, an average of 1 year.', 'description': '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.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of first drug administration to the date of death from any cause, an average of 2 year.', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'IInclusion Criteria\n\n1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.\n2. Adequate bone marrow and other vital organ functions\n3. Adequate liver function tests\n4. Metastatic Castration-resistant Prostate Cancer\n\nExclusion Criteria\n\n1. Plan to receive any other anti-tumor therapy during the study.\n2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.\n3. Uncontrolled hypertension (systolic blood pressure \\[SBP\\] \\> 150 mmHg and/or diastolic blood pressure \\[DBP\\] \\> 100 mmHg with regular anti-hypertension therapy).\n4. 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.\n5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).\n6. Active heart disease within 6 months prior to the first dosing of this study.\n7. Medical history of other malignant tumor within 5 years prior to dosing.\n8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.'}, 'identificationModule': {'nctId': 'NCT06830850', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atridia Pty Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HRS-5041-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': ': HRS-5041 dose level 1', 'description': '240 mg BID', 'interventionNames': ['Drug: HRS-5041 Single dose of HRS-5041 orally administered']}], 'interventions': [{'name': 'HRS-5041 Single dose of HRS-5041 orally administered', 'type': 'DRUG', 'description': 'HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.', 'armGroupLabels': [': HRS-5041 dose level 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'state': 'New South Wales', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'GenesisCare North Shore (Oncology)', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Gavin Marx, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sarwan Bishnoi', 'role': 'CONTACT'}, {'name': 'Sarwan Bishnoi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Research SA', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ganessan Kichenadasse', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Oncology Clinical Research Unit', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Brisbane', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jermaine Coward, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icon Cancer Centre South Brisbane', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'David Martin, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Flynn Private Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ian Davis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern Health (Box Hill Hospital)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Perth', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Timothy Humphries, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Linear Clinical Research Ltd', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Howard Gurney', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Macquarie University', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Sydney', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jane Stidworthy', 'role': 'CONTACT'}, {'name': 'Howard Gurney', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Wollongong', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Gary Tincknell, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illawarra Shoalhaven Local Health District (Wollongong Hospital)', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}], 'centralContacts': [{'name': 'Kathy You', 'role': 'CONTACT', 'email': 'kathyyou@atridia.com', 'phone': '+61 02 9299 0433'}, {'name': 'Ravi Patel', 'role': 'CONTACT', 'email': 'ravi.patel@atridia.com', 'phone': '+61 452 363 506'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atridia Pty Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}