EUCTR2014-002485-70-NL进行中（未招募）1 期
A Phase I/IIa Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
- •Expected to have life expectancy of at least 3 months
- •Men and women 18 years old or older
- •Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
- •ECOG of 0 to 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 184
排除标准
- •Cancer metastases in the brain
- •Moderate eye disorders
- •Active infection or past hepatitis B or C infection
- •Major surgery less than 1 month before the start of the study
- •Uncontrolled heart disease
- •Impaired liver or bone marrow function
- •For Part 3 only : Active, known, or suspected autoimmune disease
研究者
相似试验
进行中（未招募）
1 期
A Phase I/IIa Study of BMS-986148 in Subjects With Select Advanced Solid TumorsEUCTR2014-002485-70-BEBristol-Myers Squibb International Corporation301
进行中（未招募）
1 期
A Phase I/IIa Study of BMS-986148 in Subjects With Select Advanced Solid TumorsEUCTR2014-002485-70-GBBristol-Myers Squibb International Corporation301
终止
1 期
A Study of BMS-986148 in Patients With Select Advanced Solid TumorsAdvanced CancerNCT02341625Bristol-Myers Squibb126
进行中（未招募）
1 期
A first-in-human study to explore the BMS-986158 study drug for patients with advanced cancerSolid tumors and hematologic malignanciesMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864EUCTR2015-000324-29-BEBristol-Myers Squibb International Corporation354
进行中（未招募）
1 期
A first-in-human study to explore the BMS-986158 study drug alone and with Nivolumab for patients with advanced cancerSolid tumors and hematologic malignanciesMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864EUCTR2015-000324-29-GBBristol-Myers Squibb International Corporation354