NCT05119257Available不适用
(Bispecific) Antibodies in Cancer Patients (InHeAb01)
适应症
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
The aim of this project is to provide (bispecific) antibodies to individual patients with advanced solid and hematological malignancies without any available approved treatment options.
详细描述
Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG (German law).
All (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of advanced malignant disease
- •Advanced malignant disease without any available standard of care treatment option
- •Live expectancy > 3 month
- •Ability to understand and voluntarily sign an informed consent form.
- •Ability to adhere to the visit schedule and other protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
排除标准
- •Pregnant or lactating females.
- •Treatment regimens inducing severe T cell deficiencies
- •Treatment-related side effect from prior cancer treatment > CTC grade 2 (CTCAE V5.0)
- •Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to Ab treatment.
研究者
Prof. Dr. Helmut Salih
Head of CCU Translational Immunology (Developer and Manufacturer of applied bispecific antibodies)
University Hospital Tuebingen
研究点 (1)
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