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Glioblastom WHO Grade 4Phase 1RIT in GBMNCT05533242

Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment

A Phase 1 study testing Lu-177 labeled 6A10-Fab-fragments in people with Glioblastom WHO Grade 4, run by University Hospital Muenster at 7 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Glioblastom WHO Grade 4
What is being tested?
Lu-177 labeled 6A10-Fab-fragments
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
7 sitesGermany
Study dates
22 Jan 2024to 28 Sep 2026
Phase
Phase 1
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written patient consent after comprehensive information
  • Age between 18 and 80 years
  • Primary supratentorial high grade glioma after standard therapy (fluorescence-guided surgery, radio-chemotherapy, concomitant + adjuvant chemotherapy), with no or stable small tumor residue (residual contrast enhancement of up to 5cm3) at earliest 6 weeks after completion of radiotherapy
  • Histological verification of glioblastoma and CA 12-expression of tumor cells confirmed
  • Karnofsky-score ≥ 60
  • Volume of resection cavity 2,5-25 cm3
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  • Male and female patients with reproductive potential must use an approved contraceptive method
  • Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
  • Adequate bone marrow reserve: white blood cell (WBC) count ≥3000/μl, granulocyte count >1500/μl, platelets ≥100000/μl, hemoglobin ≥ 10 g/dl
  • Adequate liver function: bilirubin < 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3 times ULN. In the case of documented or suspected Gilbert's disease bilirubin < 3 times ULN.
  • Blood clotting: INR (=PT) and PTT within acceptable limits according to the investigator
  • Adequate renal function: creatinine < 3 times above ULN; eGFR > (or equal) 60 ml/min

Who cannot join

  • Patient unable to undergo imaging by CT, PET or contrast-enhanced MRI for whatever reason (i.e., pacemaker)
  • Resection cavity with intraventricular access
  • Significant leakage of radioactivity into CSF spaces or ventricles
  • Other actively treated invasive malignancy
  • Breastfeeding women
  • Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation, pre-existing neurological diseases except those related to glioblastoma or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
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  • Any active infection (at the discretion of the investigator)
  • Previous participation in a registered clinical trial with therapeutic intervention less than 6 weeks prior to enrolment (date of informed consent)
  • Allergy against known constituents of study medication

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Klinik für Allgemeine Neurochirurgie des Universitätsklinikums Köln

    Cologne, 50937

  • Klinik für Nuklearmedizin des Universitätsklinikums Köln

    Cologne, 50937

  • Klinik für Neurochirurgie des Universitätsklinikums Essen

    Essen, 45147

  • Klinik für Nuklearmedizin, Strahlenklinik des Universitätsklinikums Essen

    Essen, 45147

  • Klinik für Nuklearmedizin der Universität Münster

    Münster, 48149

  • Universitätsklinikum Würzburg - Neurochirurgie

    Würzburg, 97080

  • Universitätsklinikum Würzburg - Nuklearmedizin

    Würzburg, 97080

Other trials in Germany

About this study

Official title: A Phase I Trial to Determine the Maximum Tolerated Dose and Patient-specific Dosimetry of Fractionated Intracavitary Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment

Locoregional, intracavitary radioimmunotherapy (iRIT) with a newly developed radioimmunoconjugate (Lu-177 labeled 6A10-Fab-fragments) will be used to prevent or postpone tumour recurrence in patients with GBM following standard therapy .

Following study objectives will be analyzed:

  • Determining the Maximum Tolerated Dose (MTD)
  • Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher
  • Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2h,24h,48h, 72h p.i. and on day 5-7)
  • Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2h,24h,48h, 72h p.i. and on day 5-7)
  • Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion
Read the detailed description

In glioblastoma (GBM), tumour recurrence occurs adjacent to the initial tumor resection cavity in about 85% of cases (Albert et al., 1994; Bashir et al., 1988; Nestler et al., 2015). Therefore, local treatment concepts seem crucial for effective recurrence treatment strategies. We consider locoregional, intracavitary radioimmunotherapy (iRIT) to be a new therapeutic approach to delay or prevent the development of local tumour regrowth in GBM patients. By applying a radioimmunoconjugate (RIC) into the surgically created resection cavity (RC) the blood-brain barrier can effectively be by-passed, allowing the a deposit of high radiation doses locally while sparing sensitive organs like the bone marrow and the kidneys. LuCaFab (Lu-177 labeled 6A10- Fab-fragment) is a carbonic anhydrase XII-specific antibody Fab fragment developed by Helmholtz Munich, labeled with ITM's highly pure medical radioisotope, lutetium-177. (ITM IsotopeTechnologies Munich SE). Patients with GBM after standard therapy (surgery by radio-chemotherapy concomitant and adjuvant chemotherapy) Are eligible for the study. Patients will receive the calculated total doses of Lu-177-labeled 6A10-Fabs in three fractions with an interval of 4 weeks between injections, administered into the tumour cavity via an implanted reservoir. A patient specific dosing strategy will be applied and will depend on the individual RC volume. This investigator-initiated trial is sponsored by the University Hospital Münster, conducted in hospitals in Münster, Essen, Cologne, and Wuerzburg, and supported by ITM and Helmholtz Munich.

Being tested
Lu-177 labeled 6A10-Fab-fragments
Keywords
Carbonic anhydrase XII (CA XII), Intracavitary radioimmunotherapy, Fab fragment 6A10

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lu-177 labeled 6A10-Fab-fragmentsDrug

    The antibody 6A10 is a specific CA12 Inhibitor, a highly specific glioma cell-associated enzyme; all tumor cells are CA12-positive, while its expression in normal brain is very low, and Lu-177 has a comparable β-emission, but a significantly low γ-Emission.

Study groups in NCT05533242
Study groupRoleWhat they receive
Lu-177-labeled-6A10Fab-fragmentsExperimentalThe patient will receive a predetermined dose of Lu-177-labeled- 6A10Fab-fragments via the intracavitary reservoir. Patients will receive 3 RIT-cycles with an interval of 4 weeks. The total activity, adjusted to the volume of the RC, will be injected in 3 fractions with 50%, 25% and 25% of the total activity to achieve the desired boost to the 2 cm margin.
Receives: Drug: Lu-177 labeled 6A10-Fab-fragments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Determine maximum tolerated dose (MTD) and safety of adjuvant radio-immunotherapy (RIT) with Lu-177 labeled 6A10-Fab-fragments

    Measured: Through study completion, ca 1 ½ years

  2. Safety of the adjuvant radio-immunotherapy

    Determining safety by assessing all new neurological, hematological and other AEs CTC grade 2 or higher

    Measured: Through study completion, ca 1 ½ years

Secondary outcomes (2)

  1. Evaluation of pharmacokinetics of Lu-177 labeled 6A10 Fab fragments

    Determining absorbed dose to the 2 cm shell of the resection cavity (based on a series of SPECT/CTs of the head 2 ,24 ,48, 72 hours post injection and on day 5-7). Determining absorbed dose values for the kidneys, the liver, the active marrow (based on a series of SPECT/CTs of the abdomen 2 ,24 ,48, 72 hours post injection and on day 5-7)

    Measured: After first application: 2 ,24 ,48, 72 hours post injection and on day 5-7. After second and third application.

  2. Progression-free survival (PFS)

    Determining 24 weeks Progression-Free-Survival (PFS), defined from the day of inclusion

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start22 Jan 2024
  3. Primary completion28 Sep 2026
  4. Study completion28 Sep 2026

Why it stopped: The remaining shelf-life of 1 component used in the manufacture of the study medication (SM) was insufficient to support further study conduct, and no additional material could be manufactured. Production of a new SM is planned for further projects.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A modified 3+3 design is used. The applied dose of Lu-177-labeled-6A10Fab-fragments to the resection cavity will be escalated in three cohorts until the maximum tolerated dose (MTD) is determined.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05533242
Sponsor's protocol ID
UKM15_0027
Acronym
RIT in GBM
Status last verified
May 2026
First submitted
25 Jul 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fiedler L, Kellner M, Gosewisch A, Oos R, Boning G, Lindner S, Albert N, Bartenstein P, Reulen HJ, Zeidler R, Gildehaus FJ. Evaluation of 177Lu[Lu]-CHX-A''-DTPA-6A10 Fab as a radioimmunotherapy agent targeting carbonic anhydrase XII. Nucl Med Biol. 2018 May;60:55-62. doi: 10.1016/j.nucmedbio.2018.02.004. Epub 2018 Mar 4.

    PubMed 29571067

  • Alterio V, Kellner M, Esposito D, Liesche-Starnecker F, Bua S, Supuran CT, Monti SM, Zeidler R, De Simone G. Biochemical and Structural Insights into Carbonic Anhydrase XII/Fab6A10 Complex. J Mol Biol. 2019 Dec 6;431(24):4910-4921. doi: 10.1016/j.jmb.2019.10.022. Epub 2019 Nov 1.

    PubMed 31682835

  • Battke C, Kremmer E, Mysliwietz J, Gondi G, Dumitru C, Brandau S, Lang S, Vullo D, Supuran C, Zeidler R. Generation and characterization of the first inhibitory antibody targeting tumour-associated carbonic anhydrase XII. Cancer Immunol Immunother. 2011 May;60(5):649-58. doi: 10.1007/s00262-011-0980-z. Epub 2011 Feb 5.

    PubMed 21298264

  • Gondi G, Mysliwietz J, Hulikova A, Jen JP, Swietach P, Kremmer E, Zeidler R. Antitumor efficacy of a monoclonal antibody that inhibits the activity of cancer-associated carbonic anhydrase XII. Cancer Res. 2013 Nov 1;73(21):6494-503. doi: 10.1158/0008-5472.CAN-13-1110. Epub 2013 Sep 12.

    PubMed 24030978

  • Proescholdt MA, Mayer C, Kubitza M, Schubert T, Liao SY, Stanbridge EJ, Ivanov S, Oldfield EH, Brawanski A, Merrill MJ. Expression of hypoxia-inducible carbonic anhydrases in brain tumors. Neuro Oncol. 2005 Oct;7(4):465-75. doi: 10.1215/S1152851705000025.

    PubMed 16212811

  • Supuran CT. Carbonic anhydrase inhibitors as emerging agents for the treatment and imaging of hypoxic tumors. Expert Opin Investig Drugs. 2018 Dec;27(12):963-970. doi: 10.1080/13543784.2018.1548608. Epub 2018 Nov 22.

    PubMed 30426805

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lu-177 labeled 6A10-Fab-fragments in people with Glioblastom WHO Grade 4, run by University Hospital Muenster at 7 sites 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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The remaining shelf-life of 1 component used in the manufacture of the study medication (SM) was insufficient to support further study conduct, and no additional material could be manufactured. Production of a new SM is planned for further projects.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Through study completion, ca 1 ½ years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05533242, which also lists 6 linked publications.

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 13 Oct 2026.

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