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Lu-NeoB

Phase 1

Newly Diagnosed and Recurrent Glioblastoma | Small molecule | Oncology |Novartis AG|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05739942Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent GlioblastomaPHASE1 ACTIVE NOT_RECRUITING 42May 15, 2024Nov 8, 2028May 14, 202616 United States, France +4
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Study Endpoints
Primary Endpoints
Incidence and nature of Dose Limiting Toxicity (DLTs)
Up to 8 weeks (newly diagnosed glioblastoma (GBM)) or 6 weeks (recurrent GBM) after the first administration of [177Lu]Lu-NeoB

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT observation period of \[177Lu\]Lu-NeoB. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. In Group 1 (newly diagnosed GBM), the DLT observation period is defined as a total of 8 weeks (56 days) from the first administration of \[177Lu\]Lu-NeoB, to cover the entire duration of concomitant RT and TMZ combination with the first two administrations of \[177Lu\]Lu-NeoB. In Group 2 (recurrent GBM), the DLT observation period is 6 weeks (42 days) starting from the first administration of \[177Lu\]Lu-NeoB (at Week 1 Day 1) and accounting for assessment of the safety profile during 2 full cycles of \[177Lu\]Lu-NeoB.

Secondary Endpoints
Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs), changes in laboratory parameters, vital signs and Electrocardiogram (ECGs)
From date of enrollment till 28 days after end of Treatment, assessed up to approximately 17 months
Absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions
Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 3 weeks (recurrent GBM) or 4 weeks (newly diagnosed GBM))
Concentration of [177Lu]Lu-NeoB in blood over time
Cycle 1: Day1 (Pre-dose (before start of infusion), end of infusion, 0.5, 1, 2, 4 and 6 hours (hr) post-dose/post-infusion (p.i.)), Day2 (24 hr p.i), Day3 (48 hr p.i), Day8 (168 h p.i) (1 cycle= 3 weeks (recurrent GBM) or 4 weeks (newly diagnosed GBM))
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[177Lu]Lu-NeoB in Combination with Radiotherapy (RT) and Temozolomide (TMZ)EXPERIMENTALIn newly diagnosed glioblastoma
[177Lu]Lu-NeoB as Single AgentEXPERIMENTALIn recurrent glioblastoma
Interventions
NameTypeDescription
[177Lu]Lu-NeoBDRUGRadiopharmaceutical solution for infusion
[68Ga]Ga-NeoBDRUGEither provided as Kit for the radiopharmaceutical preparation of \[68Ga\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection
TemozolomideOTHERCapsules/ lyophilized powder in single-dose vial for reconstitution.
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria/Common Criteria (Group 1 - Newly diagnosed glioblastoma, Group 2 - Recurrent glioblastoma): 1. Signed informed consent must be obtained prior to participation in the study 2. Age \>= 18 years 3. Histologically confirmed glioblastoma according to WHO classification established...

Countries:United StatesFranceGermanyItalyPortugalSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05739942Enrollment: 40 → 42
LOWMay 24, 2026NCT05739942studyFirstPostDate: changed