Clinical Trials in the USA / NCT05109728
Active, not recruiting
Phase 1
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.
NCT05109728 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Glioblastoma
Investigational drug(s) / intervention(s)
[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 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.
[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)
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)
Radiotherapy: 2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks
Study 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
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 (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:
1. Residual and measurable disease post-surgery is not required but surgery must have confirmed the diagnosis of recurrence
2. 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
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
* Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of \[68Ga\]Ga-DOTA-TATE or \[177Lu\]Lu-DOTA-TATE
Newly diagnosed glioblastoma (Group 1):
• Any prior treatment for glioma of any grade
Recurrent glioblastoma (Group 3 dose escalation and expansion):
* Early disease progression prior to 3 months from the completion of radiotherapy
* Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g. edema reduction) within 60 days of initiation of study treatment
Recurrent glioblastoma (Group 3 dose escalation only):
• More than 2 prior lines for systemic therapy
Recurrent glioblastoma (Group 3 dose expansion only):
• More than 1 prior line for systemic therapy
Primary outcome measure(s)
- Group 1: Frequency of dose limiting toxicities (DLTs) — 49 to 52 days starting from first administration of [177Lu]Lu-DOTA-TATE
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that meets any of the criteria defining dose-limiting toxicities and with an onset during the DLT observation period specified for the group. • Group 1: DLT observation period of 49 to 52 days starting from the first administration of \[177Lu\]Lu-DOTA-TATE (Day 1) and ending with the completion of concomitant RT and TMZ. The 49 to 52 days observation period is depending on the start day of concomitant RT and TMZ (i.e. 7-10 days post first \[177Lu\]Lu-DOTA-TATE dose). If the concomitant RT and TMZ is delayed for any reason, the DLT observation period will last until the completion of the concomitant treatment. If RT or TMZ is delayed, the DLT observation period will last until the last administered dose, whichever occurs later. - Group 3: Frequency of dose limiting toxicities (DLTs) — 42 days starting from first administration of [177Lu]Lu-DOTA-TATE
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that meets any of the criteria defining dose-limiting toxicities and with an onset during the DLT observation period specified for the group. • Group 3: DLT observation period of 42 days starting from the first administration of \[177Lu\]Lu-DOTA-TATE (Day 1) i.e. accounting for 2 cycles of Lu\]Lu-DOTA-TATE.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Col Uni Med Center New York Presby | New York | New York | |
| University of Pittsburgh | Pittsburgh | Pennsylvania | |
| MD Anderson Cancer Center Uni of Te | Houston | Texas | |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | |
| Novartis Investigative Site | Bron | France | |
| Novartis Investigative Site | Marseille | France | |
| Novartis Investigative Site | Porto | Portugal | |
| Novartis Investigative Site | Granada | Andalusia | |
| Novartis Investigative Site | Barcelona | Spain | |
| Novartis Investigative Site | Barcelona | Spain | |
| Novartis Investigative Site | Madrid | Spain | |
| Novartis Investigative Site | Madrid | Spain | |
| Novartis Investigative Site | Lausanne | Switzerland | |
| Novartis Investigative Site | Zurich | Switzerland |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05109728 on ClinicalTrials.gov ↗ ← All trials in the USA