Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-29 @ 3:19 AM
Study NCT ID:
NCT06202261
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'C490954', 'term': 'eribulin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': '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'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-10', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'Baseline up to 4 months', 'description': 'The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.'}, {'measure': 'Phase II recommended dose (P2RD)', 'timeFrame': 'Baseline up to 1 year', 'description': 'Optimal tolerated dose determined after the end of phase 1'}, {'measure': 'Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1', 'timeFrame': 'Baseline up to 2 year', 'description': 'The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.', 'description': 'Incidence of anti-drug antibody (ADA)'}, {'measure': 'Peak concentration (Cmax), QW', 'timeFrame': 'Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.', 'description': 'The maximum serum concentration after administration'}, {'measure': 'Peak concentration (Cmax), Q2W', 'timeFrame': 'Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.', 'description': 'The maximum serum concentration after administration'}, {'measure': 'Peak concentration (Cmax), Q3W', 'timeFrame': 'Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.', 'description': 'The maximum serum concentration after administration'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Baseline up to 4 years', 'description': 'From randomization to the time of death from any cause.'}, {'measure': 'Adverse event rate', 'timeFrame': 'Baseline up to 2 years', 'description': 'The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Baseline up to 1 year', 'description': 'The time between the first medication and disease progression (PD) or death before PD.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Baseline up to 2 years', 'description': 'The ratio of disease control cases (partial remission, complete response, stable disease) to total cases.'}, {'measure': 'Duration of remission (DOR)', 'timeFrame': 'Baseline up to 2 years', 'description': 'The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death.'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Baseline up to 2 years', 'description': 'The ratio of disease control cases (partial remission, complete response, stable disease ≥ 6 month) to total cases.'}, {'measure': 'Peak concentration (Cmax), arm 2', 'timeFrame': 'Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.', 'description': 'The maximum serum concentration after administration in arm 2'}, {'measure': 'Peak concentration (Cmax), arm 3 and 4', 'timeFrame': 'Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 21 days.', 'description': 'The maximum serum concentration after administration in arm 3 and 4.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer', 'Recurrent Breast Cancer', 'Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\\~1; The expected survival is over 3 months.\n* Phase Ib\n\n 1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;\n 2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;\n 3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria\n* Phase II\n\n 1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:\n 2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;\n 3. at least one measurable lesion that meets the RECIST 1.1 criteria.\n* Major organs are functioning normally.\n* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.\n\nExclusion Criteria:\n\n* Have occured other malignant tumors within 3 years prior to first dose.\n* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Arterial/venous thrombosis events occurred within 6 months before the first dose;\n* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;\n* Subject with any severe and/or uncontrolled disease;\n* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;\n* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;\n* Severe bone injury due to bone metastasis;\n* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;\n* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \\<50% or absolute LVEF decreased \\>15%;\n* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \\>360 mg/m2;\n* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy\n* Patients with severe hypersensitivity after the use of monoclonal antibodies;\n* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose."}, 'identificationModule': {'nctId': 'NCT06202261', 'briefTitle': 'A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'TQB2930-Ib/II-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2930 for injection', 'description': 'TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.', 'interventionNames': ['Drug: TQB2930 for injection']}, {'type': 'EXPERIMENTAL', 'label': 'TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)', 'description': 'TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle', 'interventionNames': ['Drug: TQB2930 for injection', 'Drug: Paclitaxel for injection (albumin-bound)']}, {'type': 'EXPERIMENTAL', 'label': 'TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection', 'description': 'TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.', 'interventionNames': ['Drug: TQB2930 for injection', 'Drug: TQB3616 capsule', 'Drug: Fulvestrant injection']}, {'type': 'EXPERIMENTAL', 'label': 'TQB2930 for injection + chemotherapy', 'description': 'TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.', 'interventionNames': ['Drug: TQB2930 for injection', 'Drug: Capecitabine tablets', 'Drug: Vinorelbine tartrate injection', 'Drug: Eribulin mesylate injection', 'Drug: gemcitabine hydrochloride for injection']}], 'interventions': [{'name': 'TQB2930 for injection', 'type': 'DRUG', 'description': 'TQB2930 for injection is a HER2 bispecific antibody.', 'armGroupLabels': ['TQB2930 for injection', 'TQB2930 for injection + chemotherapy', 'TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)', 'TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection']}, {'name': 'Paclitaxel for injection (albumin-bound)', 'type': 'DRUG', 'description': 'It is an anti-microtubule chemotherapy drug', 'armGroupLabels': ['TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)']}, {'name': 'TQB3616 capsule', 'type': 'DRUG', 'description': 'TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.', 'armGroupLabels': ['TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection']}, {'name': 'Fulvestrant injection', 'type': 'DRUG', 'description': 'Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol', 'armGroupLabels': ['TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection']}, {'name': 'Capecitabine tablets', 'type': 'DRUG', 'description': 'Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.', 'armGroupLabels': ['TQB2930 for injection + chemotherapy']}, {'name': 'Vinorelbine tartrate injection', 'type': 'DRUG', 'description': 'Vinorelbine is an anti-tumor drug of vinca alkaloids.', 'armGroupLabels': ['TQB2930 for injection + chemotherapy']}, {'name': 'Eribulin mesylate injection', 'type': 'DRUG', 'description': 'Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.', 'armGroupLabels': ['TQB2930 for injection + chemotherapy']}, {'name': 'gemcitabine hydrochloride for injection', 'type': 'DRUG', 'description': 'Gemcitabine is a cell cycle specific anti-metabolic anticancer agent', 'armGroupLabels': ['TQB2930 for injection + chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Zeng', 'role': 'CONTACT', 'email': 'zengxiaohua000017@163.com', 'phone': '13983687701'}], 'facility': 'Affiliated Cancer Hospital of Chongqing University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang, Doctor', 'role': 'CONTACT', 'email': 'sy86298276@163.com', 'phone': '+86 0451 86298070'}], 'facility': 'Affiliated cancer hospital of harbin medical university', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Qingyuan Zhang, Doctor', 'role': 'CONTACT', 'email': 'sy86298276@163.com', 'phone': '+86 0451 86298070'}, {'name': 'Xiaohua Zeng, Doctor', 'role': 'CONTACT', 'email': 'zengxiaohua000017@163.com', 'phone': '13983687701'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}