Metastatic Breast Cancer Clinical Trial
Official title:
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
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).
Status | Recruiting |
Enrollment | 154 |
Est. completion date | October 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; The expected survival is over 3 months. - Phase Ib 1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification; 2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment; 3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria - Phase II 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: 2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines; 3. at least one measurable lesion that meets the RECIST 1.1 criteria. - Major organs are functioning normally. - 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. Exclusion Criteria: - Have occured other malignant tumors within 3 years prior to first dose. - Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment; - Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose; - Long-term unhealed wounds or fractures; - Arterial/venous thrombosis events occurred within 6 months before the first dose; - Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders; - Subject with any severe and/or uncontrolled disease; - 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; - Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose; - Severe bone injury due to bone metastasis; - Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis; - In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to <50% or absolute LVEF decreased >15%; - Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes >360 mg/m2; - Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy - Patients with severe hypersensitivity after the use of monoclonal antibodies; - Has participated in other antitumor clinical trials within 4 weeks prior to the first dose. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Cancer Hospital of Chongqing University | Chongqing | Chongqing |
China | Affiliated cancer hospital of harbin medical university | Harbin | Heilongjiang |
Lead Sponsor | Collaborator |
---|---|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) | The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects. | Baseline up to 4 months | |
Primary | Phase II recommended dose (P2RD) | Optimal tolerated dose determined after the end of phase 1 | Baseline up to 1 year | |
Primary | Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 | 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. | Baseline up to 2 year | |
Secondary | Immunogenicity | Incidence of anti-drug antibody (ADA) | 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. | |
Secondary | Peak concentration (Cmax), QW | The maximum serum concentration after administration | 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. | |
Secondary | Peak concentration (Cmax), Q2W | The maximum serum concentration after administration | 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. | |
Secondary | Peak concentration (Cmax), Q3W | The maximum serum concentration after administration | 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. | |
Secondary | Overall survival (OS) | From randomization to the time of death from any cause. | Baseline up to 4 years | |
Secondary | Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 2 years | |
Secondary | Progression-free survival (PFS) | The time between the first medication and disease progression (PD) or death before PD. | Baseline up to 1 year | |
Secondary | Disease control rate (DCR) | The ratio of disease control cases (partial remission, complete response, stable disease) to total cases. | Baseline up to 2 years | |
Secondary | Duration of remission (DOR) | The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death. | Baseline up to 2 years | |
Secondary | Clinical benefit rate (CBR) | The ratio of disease control cases (partial remission, complete response, stable disease = 6 month) to total cases. | Baseline up to 2 years | |
Secondary | Peak concentration (Cmax), arm 2 | The maximum serum concentration after administration in arm 2 | 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. | |
Secondary | Peak concentration (Cmax), arm 3 and 4 | The maximum serum concentration after administration in arm 3 and 4. | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
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