InHeAb01: (Bispecific) Antibodies in Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented diagnosis of advanced malignant disease
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Advanced malignant disease without any available standard of care treatment option
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Live expectancy > 3 month
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Ability to understand and voluntarily sign an informed consent form.
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Ability to adhere to the visit schedule and other protocol requirements
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Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
Exclusion Criteria:
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Pregnant or lactating females.
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Treatment regimens inducing severe T cell deficiencies
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Treatment-related side effect from prior cancer treatment > CTC grade 2 (CTCAE V5.0)
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Tuebingen | Tuebingen | Baden-Wuerttemberg | Germany | 72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- InHeAb01