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.

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

ClinicalTrials.gov Identifier: NCT05109728

Novartis Reference Number: CAAA601A52101

Last Update: May 16, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study aims to establish the recommended dose of [177Lu]Lu-DOTA-TATE in combination with the standard of care or as single agent in three different groups of participants with Glioblastoma. In addition, this study will investigate the safety of [68Ga]Ga-DOTA-TATE and describe its uptake characteristics in participants with Glioblastoma.

Condition 
Glioblastoma
Phase 
Phase 1
Overall status 
Recruiting
Start date 
May 31, 2022
Completion date 
Mar 12, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
[177Lu]Lu-DOTA-TATE
Group 1: [177Lu]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 4 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed. Group 2: [177Lu]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 4 weeks (Day 1, Day 29 and Day 57) and every 3 weeks in Maintenance phase. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed. Group 3: [177Lu]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 3 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed.
Drug
[68Ga]Ga-DOTA-TATE
2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)
Other
Temozolomide
Concomitant Phase: Temozolomide 75mg/m2/d p.o until last day of EBRT. Maintenance Phase: Temozolomide p.o 150 mg/m2/d during cycle 1 then 200 mg/m2/d for the following cycles if tolerated well in Cycle 1. 6 cycles total (1 cycle = every 28 days)
Other
Radiotherapy
2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks

Eligibility Criteria

Key Inclusion Criteria:

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:

Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI)
Karnofsky Performance Score (KPS) >= 70 %

Recurrent Glioblastoma:

Participant has experienced first or second recurrence of their glioblastoma, after standard or experimental therapy that includes prior radiation therapy
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 scan at the tumor region
Presence of Gadolinium enhancement in the tumor region in MRI at the time of diagnosis of tumor recurrence

Key Exclusion Criteria:

Common Criteria:

Participant is receiving additional, concurrent, active therapy for glioblastoma outside of the trial
Extensive leptomeningeal disease
History of another active malignancy in the previous 3 years prior to study entry

Newly Diagnosed Glioblastoma:

• Any prior treatment for glioma of any grade

Recurrent Glioblastoma:

Early disease progression prior to 3 months from the completion of radiotherapy
More than 2 prior lines for systemic therapy
Previous treatment with bevacizumab

Exclusion Criteria (France Only)

• Known severe chronic or active infections

Study Locations

France
Novartis Investigative Site
Recruiting
Bron, 69677
-
France
Novartis Investigative Site
Recruiting
Marseille Cedex 05, 13885
-
France
Portugal
Novartis Investigative Site
Recruiting
Porto, 4200-072
-
Portugal
Spain
Novartis Investigative Site
Recruiting
Granada, 18014
Andalucia
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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