AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 29
- 主要终点
- Stage 1 to determine the recommended phase two dose for the randomised phase
研究概览
简要总结
The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.
详细描述
This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages.
Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel.
Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to give written informed consent and to comply with the protocol
- •Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
- •Female of age 18 years or above
- •Patients who are indicated to received first line chemotherapy with weekly paclitaxel
- •Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1
- •6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.
排除标准
- •Prior chemotherapy for metastatic breast adenocarcinoma
- •Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
- •Inflammatory carcinoma
- •Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
- •Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
- •Symptomatic known cerebral and/or leptomeningeal metastases
- •Serious intercurrent infection
- •Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
- •Active acute or chronic infection
- •Active autoimmune disease requiring immunosuppressive therapy
- •Previous malignancies within the last three years other than breast carcinoma
- •Patients with prior organ or stem cell transplantation
- •Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
研究组 & 干预措施
Paclitaxel + IMP321 at the RPTD
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
干预措施: IMP321 (eftilagimod alpha) (Biological)
Paclitaxel + IMP321 at the RPTD
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, either IMP321, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (IMP321) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
干预措施: Paclitaxel (Drug)
Comparator: Paclitaxel + Placebo
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
干预措施: Placebo (Drug)
Comparator: Paclitaxel + Placebo
The chemo-immunotherapy phase consists of 6 cycles of 4 weeks. Patient will receive weekly paclitaxel at Days 1, 8 and 15 with adjunctive treatment of study agent, placebo, on Days 2 and 16 of each 4-week cycle. After completion of the 6-cycle chemo-immunotherapy phase, responding or stable patients will receive study agent (placebo) every 4 weeks during the maintenance phase for an additional period of up to 12 injections
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Stage 1 to determine the recommended phase two dose for the randomised phase
时间窗: Up to 12 months
Assessment of Progression-Free Survival (PFS)
时间窗: Up to 37 month
次要结局
- Assessment of the change in quality of life (QOL)(Up to 37 months)
- Evaluation of the time to next treatment(Up to 37 months)
- Evaluation of stable disease(Up to 37 months)
- Assessment of the safety and tolerability of IMP321 as compared to placebo(Up to 19 months)
- Assessment of the overall survival (OS)(Up to 48 month)
- Stage 1: Evaluation of the pharmacokinetic e.g. Peak Plasma Concentration [Cmax](Up to 12 months)
- Evaluation of objective response rate (ORR)(Up to 37 months)