Cancer Clinical Trial - (Bispecific) Antibodies in Cancer NCT05119257

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	November 2022
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 §13 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

Cancer

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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External Links

CCU Translational Immunology

(Bispecific) Antibodies in Cancer Patients

Clinical Trial Details — Status: Available

Administrative data

Study information