Clinical Trial · NCT05739942

Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

Overview

This study will investigate different doses of \[177Lu\]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of \[177Lu\]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent \[68Ga\]Ga-NeoB and characterize its uptake in the tumor area.

Sponsor

Novartis

Phase

Phase 1

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT05739942

Drug / Compound

NeoB

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: DOTA

NeoB

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

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
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 pancreatitisKey Inclusion Criteria/Newly diagnosed glioblastoma (Group 1):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 MRIKey Inclusion Criteria/Recurrent glioblastoma (Group 2) 11. Presence of \[68Ga\]Ga-NeoB uptake by PET/CT or PET/MRI at the tumor region 12. Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT 13. Evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (mRANO) criteria. RD must be documented with at least one bi-dimensionally measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with minimal diameters of 10 mm, according to mRANO criteria. For those participants who will undergo a second surgery for recurrence, pre-surgery MRI will be used for confirmation of RD.14\. If a second surgery is performed for glioblastoma recurrence, the following criteria must be met:
residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.
Platelet count \>= 100 x 10\^9/L
Hemoglobin \>= 10.0 g/dL
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
Aspartate transaminase (AST) or Alanine transaminase (ALT) =\< 3.0 x ULN
Absolute Neutrophil Count (ANC) \>= 1.5 x 10\^9/L
Creatinine clearance \>= 60 mL/min calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation .
Histologically confirmed glioblastoma according to WHO classification established following either a surgical resection or biopsy

Exclusion

Exclusion criteria not yet provided.