A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent

Who is this study for? Patients with newly-diagnosed glioblastoma
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A Dose Finding Study of \[177Lu\]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Standard of Care and in Recurrent Glioblastoma as a Single Agent

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

∙ Common Criteria:

• Participant is \>= 18 years on the day of signing informed consent form

• Histologically confirmed glioblastoma

• Adequate bone marrow, organ function and electrolyte values

∙ Newly diagnosed glioblastoma (Group 1):

• Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI)

• Karnofsky Performance Score (KPS) \>= 70 %

∙ Recurrent glioblastoma (Group 3 dose Escalation only):

∙ • Participant has experienced first or second recurrence of their glioblastoma, after standard or experimental therapy that includes prior EBRT

∙ Recurrent glioblastoma (Group 3 dose escalation and expansion):

• Evidence of recurrent disease demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (mRANO) criteria

• KPS \>= 60 %

• \[68Ga\]Ga-DOTA-TATE uptake by positron emission tomography/computed tomography (PET/CT) or PET/MRI at the tumor region

• Presence of Gadolinium enhancement in the tumor region in MRI at the time of diagnosis of tumor recurrence

• A second surgery for glioblastoma is allowed provided that the following criteria are met:

‣ Residual and measurable disease post-surgery is not required but surgery must have confirmed the diagnosis of recurrence

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

‣ Recurrent glioblastoma (Group 3 Dose Expansion only):

• Patients experiencing first recurrence of their glioblastoma, after standard or experimental therapy that includes prior EBRT

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
New York
Col Uni Med Center New York Presby
RECRUITING
New York
Pennsylvania
University of Pittsburgh
ACTIVE_NOT_RECRUITING
Pittsburgh
Texas
MD Anderson Cancer Center Uni of Te
RECRUITING
Houston
Wisconsin
University of Wisconsin School of Medicine and Public Health
RECRUITING
Madison
Other Locations
France
Novartis Investigative Site
RECRUITING
Bron
Novartis Investigative Site
COMPLETED
Marseille
Portugal
Novartis Investigative Site
RECRUITING
Porto
Spain
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barcelona
Novartis Investigative Site
COMPLETED
Barcelona
Novartis Investigative Site
COMPLETED
Granada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madrid
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madrid
Switzerland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lausanne
Novartis Investigative Site
RECRUITING
Zurich
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-05-10
Estimated Completion Date: 2026-02-25
Participants
Target number of participants: 60
Treatments
Experimental: Group 1 - Newly diagnosed GB
Participants with newly diagnosed glioblastoma will receive \[177Lu\]Lu-DOTA-TATE every 4 weeks +/- 2 days, starting 7 to 10 days prior to initiation of Radiotherapy (RT) and Temozolomide (TMZ)
Experimental: Group 3 - Recurrent GB
Participants with recurrent glioblastoma will receive \[177Lu\]Lu-DOTA-TATE as single agent therapy every 3 weeks +/- 2 days
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov