CancerInHeAb01NCT05119257
(Bispecific) Antibodies in Cancer Patients
A study testing Bispecific antibodies (bsAB) in people with Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Bispecific antibodies (bsAB)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
- Available
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Helmut R Salih, Prof., +49(0)707129 ext. 83275, helmut.salih@med.uni-tueningen.de
Juliane walz, Prof., +49(0)707129 ext. 68746, julian.walz@med.uni-tuebingen.de
About this study
Official title: (Bispecific) Antibodies in Cancer Patients (InHeAb01)
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Bispecific antibodies (bsAB)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Helmut Salih, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119257
- Sponsor's protocol ID
- InHeAb01
- Acronym
- InHeAb01
- Status last verified
- May 2024
- First submitted
- 18 Oct 2021
- Last updated
- 8 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Bispecific) Antibodies in Cancer Patients (InHeAb01)
- ClinicalTrials.gov ID
- NCT05119257
- Acronym / sponsor ID
- InHeAb01 / InHeAb01
- Conditions
- Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- CCU Translational ImmunologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispecific antibodies (bsAB) in people with Cancer, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helmut R. Salih, Prof. (+497071/2983275, helmut.salih@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.