(Bispecific) Antibodies in Cancer Patients | NCT05119257

Studies
(Bispecific) Antibodies in Cancer Patients

NCT05119257

Sponsor

University Hospital Tuebingen

Status

Available

Last Update Posted

May 8, 2024Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Cancer

Interventions

Bispecific antibodies (bsAB)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 2021

First Submission Date that Met QC Criteria

Oct 30, 2021

First Posted Date

Nov 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Helmut Salih, Head of CCU Translational Immunology (Developer and Manufacturer of applied bispecific antibodies), University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual PatientsIntermediate-type Population

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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 Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Helmut R. Salih, Prof.	Contact	+497071/2983275		helmut.salih@med.uni-tuebingen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen	Available	Tübingen	Baden-Wurttemberg	72076	Germany

Label	URL
CCU Translational Immunology	View source

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D018033	Antibodies, Bispecific

Ancestor Terms

ID	Term
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins

Browse Leaves

Not provided

Browse Branches

Not provided