NCT04950075进行中（未招募）2 期
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 126
- 主要终点
- Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
研究概览
简要总结
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
详细描述
This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
- •Measurable disease by RECISTv1.
- •Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
- •Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
- •Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Estimated life expectancy of at least 12 weeks.
- •Availability of archival tissue or fresh cancer biopsy are mandatory.
排除标准
- •Any prior exposure to DR5 agonists.
- •Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
- •Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
- •Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
- •Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
- •Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
- •Other exclusion criteria per protocol.
研究组 & 干预措施
INBRX-109
Experimental
IV every three weeks
干预措施: INBRX-109 (Drug)
Placebo
Placebo Comparator
IV every three weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
时间窗: 3 years
Progression-free survival per RECISTv1.1 will be determined.
次要结局
- To evaluate the safety and tolerability of INBRX-109(3 years)
- Overall survival of patients comparing INBRX-109 and placebo(3 years)
- ORR per RECISTv1.1 by real-time IRR.(3 years)
- PFS per RECISTv1.1 by Investigator assessment(3 years)
- Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo(3 years)
- DCR per RECISTv1.1 by real-time IRR(3 years)
- DOR per RECISTv1.1 by real-time IRR(3 years)
- Characterize the pharmacokinetics of INBRX-109.(3 years)
- Immunogenicity of INBRX-109(3 years)
研究者
研究点 (126)
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