Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07173556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2025-09-07', 'studyFirstSubmitQcDate': '2025-09-07', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability (Phase Ib)', 'timeFrame': 'Throughout phase Ib (approximately 1 year)', 'description': 'Types, incidence, and severity grades of AEs/SAEs and safety abnormalities, and their relationship to the investigational product; proportion of patients requiring dose adjustments or treatment discontinuation due to drug-related AEs.'}, {'measure': 'Recommended phase II dose (RP2D) (Phase Ib)', 'timeFrame': 'Throughout phase Ib (approximately 1 year)', 'description': 'RP2D will be selected upon safety, PK and efficacy data.'}, {'measure': 'Objective Response Rate (ORR) (Phase II)', 'timeFrame': 'From time of Informed Consent to confirmed progressive disease (approximately 1 year)', 'description': 'Objective Response Rate (ORR) as assessed by investigators per RECIST v1.1 criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Voluntarily participate in the clinical trial, understand and sign the informed consent form, and agree to comply with the requirements specified in the protocol.\n* Age ≥ 18 years.\n* Female subjects must be postmenopausal and meet the trial requirements.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed breast cancer.\n* Based on the most recent biopsy results of primary or metastatic tumor tissue, immunohistochemistry (IHC) confirms ER-positive status and HER-2-negative status.\n* At least one measurable target lesion according to RECIST v1.1.\n* Adequate bone marrow function within 2 weeks (14 days) prior to the initiation of study treatment, without the need for transfusion or growth factor (G-CSF, EPO, TPO, etc.) support.\n* Adequate liver function.\n* Renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Ccr) \\> 30 mL/min, with no significant electrolyte imbalances that are difficult to correct.\n* Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n* Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.\n* Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.\n* Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.\n* Prior treatment with an experimental SERD or experimental ER antagonist.\n* Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.\n* Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.\n* Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.\n* History of other active malignancies within 5 years prior to the first dose of the investigational drug.\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.\n* Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.\n* Current documented grade 1 or higher pneumonitis or interstitial lung disease.\n* Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.\n* Clinically significant uncontrolled cardiac disease and/or recent cardiac events.\n* History of bleeding tendency, thrombosis, or tumor embolism.\n* Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.\n* Allergy to any of the investigational medicinal products or their components."}, 'identificationModule': {'nctId': 'NCT07173556', 'briefTitle': 'A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study', 'orgStudyIdInfo': {'id': 'QLC1401-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLC1401 in combination with CDK4/6 inhibitors', 'interventionNames': ['Drug: QLC1401']}, {'type': 'EXPERIMENTAL', 'label': 'QLC1401 in combination with mTOR inhibitors', 'interventionNames': ['Drug: QLC1401']}], 'interventions': [{'name': 'QLC1401', 'type': 'DRUG', 'description': 'CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib', 'armGroupLabels': ['QLC1401 in combination with CDK4/6 inhibitors']}, {'name': 'QLC1401', 'type': 'DRUG', 'description': 'mTOR inhibitors: Everolimus', 'armGroupLabels': ['QLC1401 in combination with mTOR inhibitors']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhimin Shao, MD', 'role': 'CONTACT', 'email': 'szmgcp2016@163.com', 'phone': '021-64175590'}, {'name': 'Jian Zhang, MD', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '021-64175590-81807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}