Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Signed informed consent must be obtained prior to participation in the study

• Age \>= 18 years

• Histologically confirmed glioblastoma according to WHO classification established following either a surgical resection or biopsy

• 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

• Adequate bone marrow and organ function as defined by the following laboratory values obtained prior to receiving the first study treatment:

‣ Absolute Neutrophil Count (ANC) \>= 1.5 x 10\^9/L

⁃ Platelet count \>= 100 x 10\^9/L

⁃ Hemoglobin \>= 10.0 g/dL

⁃ Creatinine clearance \>= 60 mL/min calculated by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation .

⁃ Aspartate transaminase (AST) or Alanine transaminase (ALT) =\< 3.0 x ULN

⁃ 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 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:

• residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.

• surgery completed at least 2 weeks prior to study treatment initiation, with post-surgery recovery without any complications related to surgical procedure.

Locations
United States
California
University of California LA
RECRUITING
Los Angeles
Colorado
University of Colorado Denver
RECRUITING
Aurora
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
New York
Memorial Sloan Kettering Cancer Ctr
RECRUITING
New York
Ohio
Univ Hosp Cleveland Medical Center
RECRUITING
Cleveland
Utah
Uni of Utah Huntsman Cancer Inst
RECRUITING
Salt Lake City
Other Locations
France
Novartis Investigative Site
RECRUITING
Dijon
Novartis Investigative Site
RECRUITING
Marseille
Germany
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
München
Novartis Investigative Site
RECRUITING
Rostock
Israel
Novartis Investigative Site
RECRUITING
Jerusalem
Italy
Novartis Investigative Site
RECRUITING
Reggio Emilia
Portugal
Novartis Investigative Site
RECRUITING
Porto
Spain
Novartis Investigative Site
RECRUITING
Badalona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Granada
Novartis Investigative Site
RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
United Kingdom
Novartis Investigative Site
RECRUITING
Liverpool
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2031-08-28
Participants
Target number of participants: 48
Treatments
Experimental: [177Lu]Lu-NeoB in Combination with Radiotherapy (RT) and Temozolomide (TMZ)
In newly diagnosed glioblastoma
Experimental: [177Lu]Lu-NeoB as Single Agent
In recurrent glioblastoma
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov