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MeningiomaPhase 1/2PROMENADENCT04997317

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide

A Phase 1/2 study testing 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over), 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 and 177Lu-DOTA-JR11 (Phase I/II) in people with Meningioma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over), 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 and 177Lu-DOTA-JR11 (Phase I/II)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSwitzerland
Study dates
21 Apr 2021to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent as documented by signature
  • Participants of any gender and of age > 18 years
  • Female participants capable of giving birth (who are not surgically sterilized or are less than 2 years in their menopause) must use a medically accepted contraceptive and must agree to use it during and till 3 months after the treatment. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)
  • Male participants must use medically accepted contraceptive during and till 3 months after treatment
  • The participants' Karnofsky Performance Status must be ≥ 60
  • The participants must be patients with a histologically or clinically confirmed (MRI + somatostatin receptor imaging) recurrent or progressive meningioma
Show all 11Show fewer
  • There must be no other standard therapeutic alternatives for the participants
  • The participants tumour must be measurable according to RECIST v1.1 with a minimal diameter of 1.0 cm.
  • The participants must have a confirmed expression of somatostatin receptor (SSTR) on 68Ga- DOTATOC positron emission computed tomography (PET)/CT scan
  • Blood parameter criteria are:
  • Leucocytes ≥ 3*109/L i) Haemoglobin ≥ 80 g/L j) Thrombocytes ≥ 90*109/L k) Estimated glomerular filtration rate ≥ 50 ml/min l) Albumin > 25g/L m) alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value n) Bilirubin ≤ 2 times upper standard value

Who cannot join

  • Known intolerance against 177Lu, DOTA, JR11, TOC or against one of the components of 177Lu-DOTA-JR11 or 177Lu-DOTATOC
  • Ongoing infection at the screening visit or a serious infection in the past 4 weeks
  • Administration of another investigational product in the last 60 days before Visit 1 Day 1
  • Prior or planed administration of a therapeutic radio-pharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
  • Any extensive Radiotherapy involving bone marrow over the last 3 months before inclusion to the study
  • Chemotherapy in the last 2 months before inclusion
  • Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
  • Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥ 9%], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Damian Wild, Prof. Dr. med. contact

+41 61 328 6683

damian.wild@usb.ch

Dominik Cordier, PD Dr. med. contact

+41 61 55 65 642

dominik.cordier@usb.ch

Switzerland1 site, 1 recruiting

  • University Hospital Basel, Department of Neurosurgery

    Basel, Canton of Basel-City, 4031

    Damian Wild, Prof. Dr. med., +41 61 328 6683, damian.wild@usb.ch

    Dominik Cordier, PD. Dr. med., +41 61 556 56 42, dominik.cordier@usb.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-Satoreotide (PROMENADE-Study)

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

Read the detailed description

The somatostatin receptor subtype 2 (sstr2) has been identifies as a peptide hormone receptor that is highly expressed in 70 - 100% of meningiomas representing an attractive target for so called "theranostic" applications combining molecular imaging and targeted radionuclide therapy with radiolabelled somatostatin analogues.The newly developed radiolabelled somatostatin antagonist 177Lu-DOTA-JR11 has been shown to exert a high binding affinity to sstr2 suggesting a higher efficacy in the treatment of advanced meningiomas than the currently available somatostatin analogues (e.g. 177Lu-DOTATOC, 177Lu-DOTATATE).Therefore, the hypothesis has been postulated that 177LuDOTA-JR11 has an improved therapeutic index (tumour-to-dose limiting organ dose ratios) compared to 177Lu-DOTATOC, and that it can be safely used for PRRT in patients with advanced, recurrent or progressive meningiomas. The aim of this 2-step Phase 0 / Phase I/II study is to a) evaluate in the same meningioma patients the therapeutic index (tumour-to-dose limiting organ dose ratios) of 177Lu-DOTA-JR11 in comparison to 177Lu-DOTATOC and b) based on the previous results, to evaluate safety and preliminary efficacy of PRRT with 177Lu-DOTA-JR11.

Conditions
Meningioma
Being tested
177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over), 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4, 177Lu-DOTA-JR11 (Phase I/II)
Keywords
tumour, intercranial neoplasms, peptide receptor radionuclide therapy (PRRT), radiolabelled somatostatin antagonists, cancer, somatostatin receptors, 177Lu-DOTA-JR11, 77Lu-DOTATOC, somatostatin receptor subtype 2 (sstr2), 177Lu-satoreotide
Medical subject headings
Meningioma, Neoplasms

What participants receive

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

  • 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over)Drug

    177Lu-DOTA-JR11 has three main components, namely the somatostatin analogue JR11, the chemical chelator group DOTA and the beta emitter 177Lutetium (177Lu). In the Phase 0 part of the study 177Lu-DOTA-JR11 will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq).

  • 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4Drug

    177Lu-DOTATOC is a therapeutic medicinal product and has 3 main components (a) 177Lutetium (177Lu), a beta-emitting radionuclide with a half-life of 6.64 days; (b) DOTA, a chemical chelator group; and (c) TOC (= [Tyr]3-octreotide) an agonistic somatostatin analogue which binds to sstr2 and sstr5 receptors. In the Phase 0 part of the study 177Lu-DOTATOC will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq). The remaining 2 cycles will be performed with an activity of 7.4 GBq 177Lu-DOTATOC (total number of cycles = 4).

  • 177Lu-DOTA-JR11 (Phase I/II)Drug

    In the phase I/II part of the study: 3 cycles of 177Lu-DOTA-JR11 will be administered with an activity of 4.5-7.4 GBq. Two additional 177Lu-DOTA-JR11 treatment cycles can be performed if clinically indicated

Study groups in NCT04997317
Study groupRoleWhat they receive
Phase 0: Group AActive comparatorCycle 1: 4.5 GBq 177Lu-DOTA-JR11 (300-1300 μg) will be administered once intravenously. Cycle 2: 4.5 GBq 177Lu-DOTATOC (≈200 μg) will be administered once intravenously (following a cross-over design). Cycle 3 and Cycle 4 will be performed for group A patients with 7.4 GBq 177Lu-DOTATOC (clinically established amount of activity). Cycle 3 and 4 are standard of care (i.e. not part of the study).
Receives: Drug: 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over); Drug: 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4
Phase 0: Group BActive comparatorCycle 1: 4.5 GBq 177Lu-DOTATOC (≈200 μg) will be administered once intravenously. Cycle 2: 4.5 GBq 177Lu-DOTA-JR11 (300-1300 μg) will be administered once intravenously (following a cross-over design). Cycle 3 and Cycle 4 will be performed for group B patients with 7.4 GBq 177Lu-DOTATOC (clinically established amount of activity). Cycle 3 and 4 are standard of care (i.e. not part of the study).
Receives: Drug: 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over); Drug: 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4
Phase I/IIActive comparator3 cycles of 177Lu-DOTA-JR11 will be administered with an activity of 4.5-7.4 GBq. Two additional 177Lu-DOTA-JR11 treatment cycles can be performed if clinically indicated
Receives: Drug: 177Lu-DOTA-JR11 (Phase I/II)

What is being measured

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

  1. Change in Tumour-to-dose limiting organ dose ratio T-to-bone marrow: Therapeutic Index (Phase 0)

    Radiation Dosimetry of the Radiopharmaceuticals 177Lu-DOTA-JR11 and 177Lu-DOTATOC. In Phase 0 the primary objective is to assess the tumour-to-bone marrow dose ratios of 177Lu-DOTA-JR11 and 177Lu-DOTATOC. In order to get kinetic information of 177Lu- DOTA-JR11 and 177Lu-DOTATOC for this task total body scintigraphy and SPECT/CT of head and abdomen (phase 0 study) or only head (phase I/II study) are performed at different time points post injection 177Lu-DOTA-JR11 or 177Lu-DOTATOC.

    Measured: 24, 48 and 168 hours (+/- 30 min up to 24 hours)

  2. Change in Tumour-to-dose limiting organ dose ratio T-to-kidney: Therapeutic Index (Phase 0)

    Radiation Dosimetry of the Radiopharmaceuticals 177Lu-DOTA-JR11 and 177Lu-DOTATOC. In Phase 0 the primary objective is to assess the tumour-to-kidney dose ratios of 177Lu-DOTA-JR11 and 177Lu-DOTATOC. In order to get kinetic information of 177Lu- DOTA-JR11 and 177Lu-DOTATOC for this task total body scintigraphy and SPECT/CT of head and abdomen (phase 0 study) or only head (phase I/II study) are performed at different time points post injection 177Lu-DOTA-JR11 or 177Lu-DOTATOC.

    Measured: 24, 48 and 168 hours (+/- 30 min up to 24 hours)

  3. Assessment of treatment safety (phase I/II) by number of AEs graded according to CTCAE v5.0

    In Phase I/II the primary objective is to assess the safety considerations of patients treated with 177Lu-DOTA-JR11 after 3 - 5 cycles of 177Lu-DOTA-JR11 PRRT: AEs graded according to CTCAE v5.0

    Measured: About 1 hour before infusion up to 41 - 45 days after infusion

Secondary outcomes (10)

  1. Tumour absorbed dose (Gy) (Phase 0 and phase I/II)

    Assessment of maximal tumour absorbed dose (Gy) and dose coefficient (mGy/MBq) (two first cycles only)

    Measured: up to 40 weeks

  2. Organ absorbed dose (Gy) (Phase 0)

    Assessment of organ absorbed dose (Gy) and dose coefficient (mGy(MBq) (two first cycles only)

    Measured: up to 40 weeks

  3. Organ and tumour residence time (Phase 0)

    Assessment of organ and tumour residence time (time integrated activity coefficient) (two first cycles only)

    Measured: up to 40 weeks

  4. Tumour-to-remaining organ dose ratio (Phase 0)

    Assessment of tumour-to-remaining organ dose ratios (not dose limiting organs, e.g. tumour-to-spleen) (two first cycles only)

    Measured: up to 40 weeks

  5. Evaluation radiation doses (Phase 0 and Phase II)

    Assessment and comparison of whole body and organ radiation doses of 177Lu-DOTA-JR11 (first cycle only)

    Measured: up to 40 weeks

  6. Early onset toxicity (Phase 0)

    Assessment of safety (early onset toxicity): Adverse events (AEs) graded according to CTCAE v5.0 (two first cycles only)

    Measured: up to 20 weeks

  7. Change in Quality of life (QoL) short form (SF) 36 questionnaire (Phase 0 and I/II)

    Assessment of QoL SF36 questionnaire: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Measured: From Screening up to 12 months after 3rd infusion

  8. Change in visual parameters (Phase 0 and Phase I/II)

    For optical nerve sheath meningiomas: Assessment of visual acuity (visual field) before and after start with PRRT.

    Measured: up to 60-70 weeks

  9. Change in Plasma Concentration [Cmax] of 177Lu-DOTA-JR11 in the human body (Phase I/II)

    Assessment of pharmacokinetics of 177Lu-DOTA-JR11 in the human body.

    Measured: up to 50 weeks

  10. Whole body and organ radiation doses (Phase I/II)

    Assessment of whole body and organ radiation doses of 177Lu-DOTA-JR11 (first cycle only)

    Measured: up to 60-70 weeks

Timeline

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

  1. First posted9 Aug 2021
  2. Study start21 Apr 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a, two-step, cross-over, open-label phase 0 study comparing the therapeutic index of 177Lu-DOTA-JR11 and 177Lu-DOTATOC followed by a single-arm open-label Phase I/II study.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04997317
Sponsor's protocol ID
2019-00303; th21Wild2
Other IDs
2019
Acronym
PROMENADE
Status last verified
Apr 2025
First submitted
19 Jul 2021
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eigler C, McDougall L, Bauman A, Bernhardt P, Hentschel M, Blackham KA, Nicolas G, Fani M, Wild D, Cordier D. Radiolabeled Somatostatin Receptor Antagonist Versus Agonist for Peptide Receptor Radionuclide Therapy in Patients with Therapy-Resistant Meningioma: PROMENADE Phase 0 Study. J Nucl Med. 2024 Apr 1;65(4):573-579. doi: 10.2967/jnumed.123.266817.

    PubMed 38423782

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over), 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 and 177Lu-DOTA-JR11 (Phase I/II) in people with Meningioma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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 Switzerland. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Damian Wild, Prof. Dr. med. (+41 61 328 6683, damian.wild@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tumour-to-dose limiting organ dose ratio T-to-bone marrow: Therapeutic Index (Phase 0) (time frame: 24, 48 and 168 hours (+/- 30 min up to 24 hours)). The study lists 3 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 NCT04997317, which also lists 1 linked publication.

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 Apr 2025.

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