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NCT05119257 Clinical Trial

(Bispecific) Antibodies in Cancer Patients

Cancer Clinical Trial

— InHeAb01  

Official title:
(Bispecific) Antibodies in Cancer Patients (InHeAb01)

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05119257
Other study ID # InHeAb01
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date May 2024
Source University Hospital Tuebingen
Contact Helmut R. Salih, Prof.
Phone +497071/2983275
Email helmut.salih@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Description:

Ethics: Patient treatment will be conducted according to ยง13 Absatz 2b, AMG (German law). All (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Bispecific antibodies (bsAB)
BsAbs equipped with a target-specificity directed to a TAA and an effector-specificity for an activating receptor on T cells, such as CD3 or CD28, are applied intravenously in repeated cycles until disease progression or dose limiting toxicity.

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen Baden-Wuerttemberg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

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