NCT07601620尚未招募1 期
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
Shanghai Henlius Biotech0 个研究点目标入组 258 人开始时间: 2026年7月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 258
- 主要终点
- Peak concentration (Cmax)
研究概览
简要总结
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
详细描述
This is a randomized, double-blind, parallel-controlled, multi-center Phase I equivalence study to compare the similarity in PK profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer with a primary tumor > 2 cm or nodes-positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).
- •Male or female aged ≥ 18 years old at the time of signing the ICF;
- •Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.
- •Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.
- •Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-
- •Adequate major organ functions.
- •Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.
排除标准
- •Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.
- •History of other malignancy within 5 years.
- •Prior systemic therapy for breast cancer treatment or radiotherapy.
- •Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.
- •Patients who have undergone excision biopsy of the primary tumor and/or axillary lymph nodes or lymph node dissection.
- •Have severe heart disease or medical conditions.
- •Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.
- •Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.
- •Daily use of corticosteroid treatment is required.
- •Sensitivity to any study medications or any of its ingredients or excipients.
- •Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.
- •Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.
- •Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.
- •Any other conditions which are inappropriate for the study in the opinion of the investigator.
研究组 & 干预措施
HLX319
Experimental
The regimen in the experimental group is HLX319 in combination with docetaxel and carboplatin.
干预措施: HLX319 (Drug)
EU-Phesgo®
Active Comparator
The regimen in the control group is EU-Phesgo® in combination with docetaxel and carboplatin.
干预措施: EU-Phesgo® (Drug)
结局指标
主要结局
Peak concentration (Cmax)
时间窗: up to 180 days
Peak concentration after a single drug administration in Cycle 1.
Area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d)
时间窗: up to 180 days
Area under the serum drug concentration-time curve from 0 to 21 days after a single drug administration in Cycle 1.
Steady-state peak concentration (Cmax,ss)
时间窗: up to 180 days
The steady-state peak concentration after multiple doses administration in Cycle 4.
Steady-state area under the serum drug concentration-time curve within a dosing interval (AUCss)
时间窗: up to 180 days
Steady-state area under the serum drug concentration-time curve within a dosing interval after multiple doses administration in Cycle 4.
次要结局
- Positivity rates of neutralizing antibodies (NAb)(up to 180 days)
- Trough concentration (Ctrough)(up to 180 days)
- Area under the serum drug concentration-time curve from time 0 to infinity (AUC0-inf)(up to 180 days)
- Percentage of extrapolated area in the total AUC (%AUCex)(up to 180 days)
- Time to peak concentration (Tmax)(up to 180 days)
- Elimination half-life (T1/2)(up to 180 days)
- Total clearance (CL/F)(up to 180 days)
- Terminal phase distribution volume (Vz/F)(up to 180 days)
- Mean residence time (MRT)(up to 180 days)
- Steady-state trough concentration (Ctrough,ss)(up to 180 days)
- Average steady-state concentration (Caverage,ss)(up to 180 days)
- Steady-state time to peak concentration (Tmax,ss)(up to 180 days)
- Elimination half-life (T1/2,ss)(up to 180 days)
- Steady-state volume of distribution (Vss/F)(up to 180 days)
- Steady-state total clearance (CLss/F)(up to 180 days)
- accumulation ratio based on Cmax (RCmax)(up to 180 days)
- Accumulation ratio based on AUC (RAUC)(up to 180 days)
- The total pathological complete response (tpCR) rate assessed by the investigator(up to 180 days)
- Breast pathologic complete response (bpCR) rate assessed by the investigator(up to 180 days)
- Objective response rate (ORR) assessed by the investigator(up to 180 days)
- Incidence and severity of adverse events (AEs)(up to 180 days)
- Number of participants with abnormal vital signs(up to 180 days)
- Number of participants with abnormal physical examination findings(up to 180 days)
- Number of participants with abnormal Laboratory tests results(up to 180 days)
- Number of participants with abnormal 12-lead ECG readings(up to 180 days)
- Positivity rates of anti-drug antibodies (ADA)(up to 180 days)
研究者
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