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NCT05739942
Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma
Phase 1 trial testing [177Lu]Lu-NeoB in Newly Diagnosed and Recurrent Glioblastoma in 42 participants. Participants enrolled and being followed up; not accepting new ones.
10 December 2026
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 15 May 2024 |
| Primary completion | 10 December 2026 |
| Estimated completion | 8 November 2028 |
| Sites | 23 locations across Portugal, United States, Germany, Spain, Italy, France |
Drugs / interventions tested
- [177Lu]Lu-NeoB — full drug profile →
- [68Ga]Ga-NeoB — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Newly Diagnosed and Recurrent Glioblastoma — all drugs for Newly Diagnosed and Recurrent Glioblastoma →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, any sex, with Newly Diagnosed and Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting epigenetic regulators as a promising avenue to overcome cancer therapy resistance.
Song J, Yang P, Chen C, Ding W, et al · · 2025 · cited 40× · PMID 40675967 · DOI 10.1038/s41392-025-02266-z -
PET imaging of gliomas: Status quo and quo vadis?
Galldiks N, Lohmann P, Friedrich M, Werner JM, et al · · 2024 · cited 21× · PMID 38970818 · DOI 10.1093/neuonc/noae078 -
Side-by-side comparison of the two widely studied GRPR radiotracers, radiolabeled NeoB and RM2, in a preclinical setting.
Damiana TST, Paraïso P, de Ridder C, Stuurman D, et al · · 2023 · cited 12× · PMID 37584725 · DOI 10.1007/s00259-023-06364-4 -
Radioligand Therapy in Cancer Management: A Global Perspective.
Ninatti G, Lee ST, Scott AM. · · 2025 · cited 5× · PMID 41228206 · DOI 10.3390/cancers17213412 -
Emerging PET Imaging Agents and Targeted Radioligand Therapy: A Review of Clinical Applications and Trials.
Palihati M, Das JP, Yeh R, Capaccione K. · · 2025 · cited 5× · PMID 40863874 · DOI 10.3390/tomography11080083 -
Innovative radiotherapies for the treatment of glioblastoma.
Van Eupen L, Waked A, Primac I, Vermeulen K, et al · · 2026 · PMID 41684714 · DOI 10.1093/noajnl/vdaf255
Verify or expand the search:
- PubMed search for NCT05739942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of [177Lu]Lu-NeoB
Trials testing the same drug.
- NCT06247995 — A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GR · Phase 1, PHASE2 · recruiting
- NCT06379217 — NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastati · Phase 1 · active not recruiting
- NCT05870579 — [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast · Phase 1 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05739942 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 3 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05739942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing