(Bispecific) Antibodies in Cancer Patients
InHeAb01
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedMay 8, 2024
May 1, 2024
October 18, 2021
May 7, 2024
Conditions
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of CCU Translational Immunology (Developer and Manufacturer of applied bispecific antibodies)
Study Record Dates
First Submitted
October 18, 2021
First Posted
November 15, 2021
Last Updated
May 8, 2024
Record last verified: 2024-05