(Bispecific) Antibodies in Cancer Patients

N/AAvailableNCT05119257

University Hospital Tuebingen

Overview

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.

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 Type

EXPANDED_ACCESS

Conditions

Cancer

Interventions

Bispecific antibodies (bsAB)BIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

AVAILABLE

Central Contacts

Helmut R. Salih, Prof.

CONTACT

+497071/2983275 helmut.salih@med.uni-tuebingen.de

Data from ClinicalTrials.gov

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