68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Norwegian University Of Science And Technolology

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-10-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Trond Mohn Foundation

External identifiers

EU CT number

2024-518495-31-00

EudraCT number

2021-006810-35

ClinicalTrials.gov

NCT05644080

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

• To evaluate safety and tolerability of 177Lu- PSMA
• To evaluate efficacy of 177Lu- PSMA in the treatment of patients with recurrent or progressed grade 3 and grade 4 glioma

Secondary objectives 3

1. Evaluate radiation dose to tumor and critical organs
2. Evaluate efficacy and side effects of treatment on patient reported, physician assessed and radiological parameters
3. Evaluate the diagnostic and theranostic properties of 68Ga-PSMA

Conditions and MedDRA coding

Recurrent grade 3 and grade 4 glioma

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma
2. Radiologically (MRI) confirmed tumor relapse/progression ≥ 12 weeks since completed radiotherapy or suspicion of recurrence where inclusion in the theranostic part of study could be indicated
3. Must be ≥ 18 years old
4. Written informed consent for study participation
5. Negative pregnancy test no longer than 14 days prior to enrollment
6. Life expectancy > 12 weeks
7. Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy)
8. High tumor uptake on diagnostic imaging with 68Ga -PSMA
9. Tumor not amendable for radiotherapy or surgery, and treating oncologist think that there are no other preferable systemic therapy options (e.g temozolomide, PCV or lomustine monotherapy)
10. Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
11. Patient accept not to receive any other tumor directed treatment during a treatment cycle (6-8 weeks)

Exclusion criteria 17

1. Estimated GFR < 30 mL/min
2. Platelet count <75 x109 /L
3. White blood cells ≤ 2.0 x 109/L
4. Neutrophil count < 1.5 x109 /L
5. Hb < 10.0 g/dL
6. Albumin ≤ 30 g/L
7. Uncontrollable symptomatic epilepsy refractory to standard medication
8. Pacemakers or defibrillators not compatible with 3T MRI
9. No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits)
10. Breastfeeding
11. Pregnancy
12. Hypersensitivity to the active substance or to any of the excipients
13. Urinary and fecal incontinence (patient cannot have diaper needs)
14. Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy
15. If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses >=23 Gy to any of the kidneys, or >= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study
16. Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry
17. Unwilling to accept potential challenge with xerostomia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2).
2. Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy

Secondary endpoints 3

1. Evaluate radiation dose to tumor and critical organs: Calculation of absorbed doses to the tumor and kidneys, parotid glands, sublingual glands, submandibular glands, lacrimal glands, liver, spleen and red marrow for each therapy cycle as well as accumulated doses for all therapy cycles.
2. Evaluate efficacy and side effects of treatment on the following from baseline to end of each treatment cycle and to the follow up examinations: o Tumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria and volume measurements. o Neurologic exam (nano score) o Health-related quality of life EQ-5D scores o Karnofsky performance status
3. Evaluate diagnostic and theranostic properties of 68Ga-PSMA

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Norwegian University Of Science And Technolology

Sponsor organisation

Norwegian University Of Science And Technolology

Address

Hoegskoleringen 1

City

Trondheim

Postcode

7034

Country

Norway

Scientific contact point

Organisation

Norwegian University Of Science And Technolology

Contact name

Tora Skeidsvoll Solheim

Public contact point

Organisation

Norwegian University Of Science And Technolology

Contact name

Tora Skeidsvoll Solheim

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications