Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT06855069
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 468}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Duration of Response (DoR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Duration of Response (DoR), assessed by BIRC as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1', 'timeFrame': 'Screening up to study completion, an average of 1 year'}, {'measure': 'Adverse Events', 'timeFrame': 'Screening up to study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platinum-resistant recurrent epithelial ovarian cancer', 'HS-20089', 'randomized', 'phase III'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': "This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary participation and written informed consent.\n2. 18 years and older, female.\n3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n4. Patients must have platinum-resistant disease\n5. Be able to provide fresh or archived tumor tissue.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.\n8. With a life expectancy \\> 12 weeks.\n9. Adequate bone marrow reserve and organ function.\n10. Contraception is required during the trial.\n\nExclusion Criteria:\n\n1. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.\n2. Previous or co-existing malignancies.\n3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.\n4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.\n5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.\n6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.\n7. Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.\n8. Other inappropriate situation considered by the investigator.'}, 'identificationModule': {'nctId': 'NCT06855069', 'briefTitle': 'HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hansoh BioMedical R&D Company'}, 'officialTitle': "A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer", 'orgStudyIdInfo': {'id': 'HS-20089-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group 1: HS-20089', 'interventionNames': ['Drug: HS-20089']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Treatment group 2: Investigator's choice of chemotherapy", 'interventionNames': ['Drug: Paclitaxel', 'Drug: Doxorubicin', 'Drug: Topotecan']}], 'interventions': [{'name': 'HS-20089', 'type': 'DRUG', 'description': 'HS-20089 dose 1', 'armGroupLabels': ['Treatment group 1: HS-20089']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel dose 2', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin dose 3', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Topotecan dose 4', 'armGroupLabels': ["Treatment group 2: Investigator's choice of chemotherapy"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lingying Wu, MD', 'role': 'CONTACT', 'email': 'wulingying@csco.org.cn', 'phone': '(+86)13910865483'}], 'overallOfficials': [{'name': 'Lingying Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hansoh BioMedical R&D Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}