A Phase Ib/II, Open-label, Multicenter Clinical Study to Evaluate the Antitumor Activities, Safety, and Tolerability of IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 7
- 主要终点
- Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody.
研究概览
简要总结
This is a multicenter, open-label, Phase Ib/II clinical trial to evaluate the safety, tolerability, and antitumor efficacy of IN10018 in combination with pegylated liposomal doxorubicin (PLD) or IN10018 in combination with PLD and anti-PD-1 in subjects with locally advanced or metastatic solid tumors who have failed or not tolerated to at least first-line system therapy.
详细描述
This study is a phase Ib/II, multicenter, open-label clinical study. This study consists of 2 parts: 1) Efficacy exploration part: including phase-Ib study (dose confirmation part) and phase II study, the purpose of phase Ib-dose confirmation part is to determine the Phase II recommended dose (RP2D) of IN10018 in combination with Pegylated liposomal doxorubicin (PLD) and programmed death-1 (PD-1) monoclonal antibody. The Phase II study will explore the antitumor efficacy and safety of IN10018 in combination with PLD or IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in subjects with locally advanced or metastatic solid tumors who have failed or are intolerant to at least first-line system therapy; 2) Efficacy confirmation part: The antitumor efficacy and safety of combination therapy in the corresponding solid tumors will be further confirmed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Triple Negative Breast Cancer(TNBC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated locally advanced or metastatic TNBC.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic TNBC.
干预措施: IN10018+PLD (Drug)
Triple Negative Breast Cancer(TNBC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated locally advanced or metastatic TNBC.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic TNBC.
干预措施: IN10018+PLD+Toripalimab (Drug)
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated R/M-HNSCC.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated R/M-HNSCC.
干预措施: IN10018+PLD (Drug)
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
Group 1: IN10018 in combination with PLD in Subjects with previously-treated R/M-HNSCC.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated R/M-HNSCC.
干预措施: IN10018+PLD+Toripalimab (Drug)
Platinum-resistant Ovarian Cancer
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.
干预措施: IN10018+PLD+Toripalimab (Drug)
Platinum-sensitive Ovarian Cancer(PSOC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.
干预措施: IN10018+PLD+Toripalimab (Drug)
Small Cell Lung Cancer(SCLC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC.
干预措施: IN10018+PLD+Toripalimab (Drug)
Other solid tumor
Group 1: IN10018 in combination with PLD in Subjects with other previously-treated locally advanced or metastatic solid tumors.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with other previously-treated locally advanced or metastatic solid tumors.
干预措施: IN10018+PLD (Drug)
Other solid tumor
Group 1: IN10018 in combination with PLD in Subjects with other previously-treated locally advanced or metastatic solid tumors.
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with other previously-treated locally advanced or metastatic solid tumors.
干预措施: IN10018+PLD+Toripalimab (Drug)
结局指标
主要结局
Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody.
时间窗: Up to 6 Months
Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with PLD and Toripalimab.
Objective response rate (ORR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.
时间窗: Up to 24 Months
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
次要结局
- Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.(Up to 24 Months)
- Duration of objective response (DOR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.(Up to 24 Months)
- Disease Control Rate (DCR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.(Up to 24 Months)
- Progression-free survival (PFS) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.(Up to 24 Months)
- Overall survival (OS) in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group.(Up to 36 Months)