(Bispecific) Antibodies in Cancer Patients

NCT ID: NCT05119257

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Cancer

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Helmut Salih

Head of CCU Translational Immunology (Developer and Manufacturer of applied bispecific antibodies)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status AVAILABLE

Countries

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Germany

Central Contacts

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Helmut R. Salih, Prof.

Role: CONTACT

+497071/2983275

Facility Contacts

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Helmut R Salih, Prof.

Role: primary

+49(0)707129 ext. 83275

Juliane walz, Prof.

Role: backup

+49(0)707129 ext. 68746

Related Links

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Other Identifiers

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InHeAb01

Identifier Type: -

Identifier Source: org_study_id

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