(Bispecific) Antibodies in Cancer Patients (InHeAb01)

University Hospital Tuebingen

Status

Conditions: Cancer

Treatments: Biological: Bispecific antibodies (bsAB)

Study type: Expanded Access

Funder types: Other

Identifiers

NCT05119257

InHeAb01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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.