Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma
NCT ID: NCT05739942
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2024-05-15
2032-07-01
Brief Summary
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Detailed Description
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Glioblastoma is the most common and aggressive type of primary brain tumor, with a high mortality rate. The current standard of care (SoC) in newly diagnosed glioblastoma includes the combination of the alkylating agent Temozolomide (TMZ) with Radiotherapy (RT). The hypothesis of this study is to improve the outcome for participants by combining the current standard of care with the radioligand therapy \[177Lu\]Lu-NeoB. Participants with newly diagnosed glioblastoma enrolled into this trial will be treated with the standard regimen TMZ and RT, combined with \[177Lu\]Lu-NeoB every 4 weeks (Q4W) for 6 administrations. In cases where participants tolerate and benefit from \[177Lu\]Lu-NeoB, they can receive an additional 4 doses (total up to 10 dose administrations). During this period, regular safety and efficacy assessments are planned on a weekly basis. The primary objective of this trial is to identify the recommended dose of \[177Lu\]Lu-NeoB in combination with TMZ and RT in participants with newly diagnosed glioblastoma and to characterize the safety and tolerability of this treatment. For this reason, participants will be enrolled and treated in cohorts with increasing dose levels and the totality of available data will be used to define the recommended dose. Contrast enhanced MRI assessments are to be repeated every 8 weeks. Following treatment, all participants will be followed for up to 5 additional years for safety, progression of disease and survival. Participants with newly diagnosed glioblastoma will undergo a baseline \[68Ga\]Ga-NeoB PET/CT or PET/MRI after the surgery/biopsy of the tumor.
Recurrent glioblastoma:
Participants with recurrent glioblastoma carry a dismal prognosis and a short survival. The primary objective in recurrent glioblastoma is to determine the recommended dose of \[177Lu\]Lu-NeoB as single agent and to characterize the safety and tolerability of this treatment. For this reason, participants will be enrolled and treated in cohorts with increasing dose levels and the totality of available data will be used to define the recommended dose. In this study, all participants with recurrent glioblastoma will undergo \[68Ga\]Ga-NeoB PET scan to assess GRPR expression during the screening period. \[177Lu\]Lu-NeoB will be administered as a single dose every 3 weeks (Q3W) for 6 administrations. Up to 4 additional administrations of \[177Lu\]Lu-NeoB may be considered if participants tolerate and benefit from \[177Lu\]Lu-NeoB (total up to 10 dose administrations).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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[177Lu]Lu-NeoB in Combination with Radiotherapy (RT) and Temozolomide (TMZ)
In newly diagnosed glioblastoma
[177Lu]Lu-NeoB
Radiopharmaceutical solution for infusion
[68Ga]Ga-NeoB
Either provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection
Temozolomide
Capsules/ lyophilized powder in single-dose vial for reconstitution.
[177Lu]Lu-NeoB as Single Agent
In recurrent glioblastoma
[177Lu]Lu-NeoB
Radiopharmaceutical solution for infusion
[68Ga]Ga-NeoB
Either provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection
Interventions
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[177Lu]Lu-NeoB
Radiopharmaceutical solution for infusion
[68Ga]Ga-NeoB
Either provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection
Temozolomide
Capsules/ lyophilized powder in single-dose vial for reconstitution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>= 18 years
3. Histologically confirmed glioblastoma according to WHO classification established following either a surgical resection or biopsy
4. Participants who are receiving corticosteroid treatment with dexamethasone, must be treated with a dose of =\<4 mg/day (or other corticosteroids at equivalent dose) for a minimum of 7 days before initiation of study treatment
5. Adequate bone marrow and organ function as defined by the following laboratory values obtained prior to receiving the first study treatment:
1. Absolute Neutrophil Count (ANC) \>= 1.5 x 10\^9/L
2. Platelet count \>= 100 x 10\^9/L
3. Hemoglobin \>= 10.0 g/dL
4. Creatinine clearance \>= 60 mL/min calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation .
5. Aspartate transaminase (AST) or Alanine transaminase (ALT) =\< 3.0 x ULN
6. Total bilirubin (TBIL) \< 1.5 × ULN (any elevated bilirubin should be asymptomatic at enrollment) except for participants with Gilbert's syndrome who may only be included if the total bilirubin is =\< 3.0 × ULN or direct bilirubin =\< 1.5 × ULN
7. Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - =\< 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
9\. Availability of tumor tissue representative of glioblastoma from definitive surgery or biopsy, to support biomarker analysis 10. Presence of gadolinium enhancement at the tumor region in the pre-surgery MRI
14\. If a second surgery is performed for glioblastoma recurrence, the following criteria must be met:
1. residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.
2. surgery completed at least 2 weeks prior to study treatment initiation, with post-surgery recovery without any complications related to surgical procedure.
Exclusion Criteria
a. Documented myocardial infarction (MI), angina pectoris, cardiomyopathy, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry b. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsade de Pointes (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia ii. Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsade de Pointes that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug) iii. Inability to determine the Fridericia QT correction formula (QTcF) interval c. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block) d. Resting QTcF \>= 450 msec (male) or \>= 460 msec (female) e. Left Ventricular Ejection Fraction (LVEF) \<50% as determined by echocardiogram (ECHO) or Multiple Gated Acquisition (MUGA) scan f. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) \>=160 mmHg and/or Diastolic Blood Pressure (DBP) \>=100 mm Hg, with or without anti-hypertensive medication.
5\. History of another active malignancy in the previous 3 years prior to study entry, except participants with prior history of superficial bladder cancer, any in situ carcinoma or basal or squamous cell skin cancer treated curatively
17\. Any prior treatment for glioma of any grade, including: prolifeprospan 20 with carmustine wafer, intracerebral agent, radiation treatment, chemotherapy or immunotherapy
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of California LA
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States
Univ Hosp Cleveland Medical Center
Cleveland, Ohio, United States
Uni of Utah Huntsman Cancer Inst
Salt Lake City, Utah, United States
Novartis Investigative Site
Dijon, Cote D Or, France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Jerusalem, , Israel
Novartis Investigative Site
Reggio Emilia, RE, Italy
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Badalona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Liverpool, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-502134-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CAAA603C12101
Identifier Type: -
Identifier Source: org_study_id
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