(Bispecific) Antibodies in Cancer Patients
- Conditions
- Cancer
- Registration Number
- NCT05119257
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Tuebingen
🇩🇪Tuebingen, Baden-Wuerttemberg, Germany