drugset / Trial / NCT03970447
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Phase 2/3
Recruiting
2250 enrolled
Global Coalition for Adaptive Research
AstraZeneca · collabBayer · collabBiohaven Pharmaceuticals, Inc. · collabKazia Therapeutics Limited · collabKintara Therapeutics, Inc. · collabKnoa Pharma · collabPolaris Group · collabVigeo Therapeutics, Inc. · collab
RandomizedSequentialOpen-labelTreatment
Summary
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\*).
Timeline
- Start
- 2019-07-30
- Primary completion
- 2028-06
- Completion
- 2030-06
Publications
- Results Wen PY, Berry DA, Buxton MB, Colman H, de Groot J, Lim M, Mellinghoff I, Perry JR, Weller M, Blondin NA, Butt OH, Damek DM, de la Fuente MI, Drappatz J, Dunbar E, Giglio P, Hyddmark EV, Iwamoto F, Jaeckle KA, Kim L, Kling HM, Lee EQ, Mantica M, Mikkelsen T, Nabors B, Newton HB, Olson JJ, Schiff D, Walbert T, Weathers SP, Cloughesy T, Lassman AB; GBM AGILE Regorafenib Study Group. Evaluation of Regorafenib in Newly Diagnosed and Recurrent Glioblastoma: GBM AGILE Phase II/III Bayesian Randomized Platform Trial. J Clin Oncol. 2026 Jun 20;44(18):1676-1686. doi: 10.1200/JCO-25-01137. Epub 2026 Apr 14.
- Chen JJ, Vincent MY, Shepard D, Peereboom D, Mahalingam D, Battiste J, Patel MR, Juric D, Wen PY, Bullock A, Selfridge JE, Pant S, Liu J, Li W, Fyfe S, Wang S, Zota V, Mahoney J, Watnick RS, Cieslewicz M, Watnick J. Phase 1 dose expansion and biomarker study assessing first-in-class tumor microenvironment modulator VT1021 in patients with advanced solid tumors. Commun Med (Lond). 2024 May 21;4(1):95. doi: 10.1038/s43856-024-00520-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD1390 | Small molecule | — | — |
| Subject | Dianhydrogalactitol | Other / unclassified | 30 mg/m2 | Intravenous |
| Comparator | Lomustine | Small molecule | 100 mg/m2 | Oral |
| Comparator | Lomustine | Small molecule | 110 mg/m2 | Oral |
| Subject | Paxalisib | Small molecule | 60 mg | Oral |
| Subject | Pegargiminase | Protein / enzyme biologic | 18 mg/m2 | Intramuscular |
| Subject | Pegargiminase | Protein / enzyme biologic | 36 mg/m2 | Intramuscular |
| Subject | Regorafenib | Small molecule | 160 mg | Oral |
| Comparator | Temozolomide | Small molecule | 200 mg/m2 | Oral |
| Subject | Tinostamustine | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Tinostamustine | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Tinostamustine | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Troriluzole | Peptide | 100 mg | Oral |
| Subject | Troriluzole | Peptide | 200 mg | Oral |
| Subject | VT1021 | Peptide | 9 mg/kg | Intravenous |
| Subject | VT1021 | Peptide | 12 mg/kg | Intravenous |