Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT07180160
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)', 'description': 'PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From the date of starting study treatment to the end of the treatment (up to approximately 1 year)', 'description': 'Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, age≥18 years old\n* Expected survival ≥12 weeks\n* ECOG 0-1\n* Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery\n* ER and/or PR positive, HER2 negative\n* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1\n* Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors\n* Adequate organ function\n\nExclusion Criteria:\n\n* During pregnancy and lactation\n* Patients with central nervous system metastasis'}, 'identificationModule': {'nctId': 'NCT07180160', 'acronym': 'ITHRAN', 'briefTitle': 'Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial', 'orgStudyIdInfo': {'id': 'LY2025-215-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QL1706', 'description': 'QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole', 'interventionNames': ['Drug: QL1706', 'Drug: CDK4/6 inhibitor', 'Drug: Fulvestrant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'CDK4/6 inhibitor + fulvestrant/letrozole', 'interventionNames': ['Drug: CDK4/6 inhibitor', 'Drug: Fulvestrant']}], 'interventions': [{'name': 'QL1706', 'type': 'DRUG', 'description': 'QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).', 'armGroupLabels': ['QL1706']}, {'name': 'CDK4/6 inhibitor', 'type': 'DRUG', 'description': 'palbociclib OR ribociclib OR abemaciclib OR dalpiciclib', 'armGroupLabels': ['QL1706', 'control']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'SERD', 'armGroupLabels': ['QL1706', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjin Yin', 'role': 'CONTACT', 'email': 'yinwenjin@renji.com', 'phone': '86(21)68385569'}], 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenjin Yin, M.D.', 'role': 'CONTACT', 'email': 'yinwenjin@renji.com', 'phone': '86(21)68385569'}], 'overallOfficials': [{'name': 'Wenjin Yin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital,School of Medicine, Shanghai Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenjin Yin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief of Breast Surgery Department', 'investigatorFullName': 'Wenjin Yin', 'investigatorAffiliation': 'RenJi Hospital'}}}}