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Tinostamustine

DRUG6 trials

Sponsors

Mundipharma Research Limited, M.D. Anderson Cancer Center, Mundipharma-EDO GmbH, Markus Joerger, Global Coalition for Adaptive Research

Conditions

Cutaneous T Cell LymphomaGlioblastomaGlioblastoma MultiformeGliosarcomaHematological MalignanciesHodgkin's LymphomaMGMT-Unmethylated GlioblastomaMalignant Melanoma

Early Phase 1

Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
CompletedNCT05432375
Mundipharma Research LimitedGlioblastoma Multiforme
Start: 2022-07-01End: 2024-11-10Updated: 2025-12-10

Phase 1

Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies
CompletedNCT02576496
Mundipharma Research LimitedCutaneous T Cell Lymphoma, Hematological Malignancies, Hodgkin's Lymphoma +1
Start: 2016-04-14End: 2023-11-21Updated: 2024-07-25
Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma
CompletedNCT03452930
M.D. Anderson Cancer CenterGlioblastoma, Gliosarcoma, MGMT-Unmethylated Glioblastoma
Start: 2018-08-13End: 2024-06-05Updated: 2025-06-04
Tinostamustine Conditioning and Autologous Stem Cell
TerminatedNCT03687125
Mundipharma-EDO GmbHMultiple Myeloma in Relapse, Multiple Myeloma Progression, Multiple Myeloma With Failed Remission
Start: 2018-10-15End: 2019-04-17Updated: 2021-06-18
Tinostamustine and Nivolumab in Advanced Melanoma
NCT03903458
Markus JoergerMalignant Melanoma
Start: 2019-03-07End: 2024-03-15Target: 21Updated: 2019-04-08

Phase 2

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
RecruitingNCT03970447
Global Coalition for Adaptive ResearchGlioblastoma
Start: 2019-07-30End: 2030-06-01Target: 2250Updated: 2026-04-03

Related Papers

CTNI-02. A PHASE 1 STUDY OF TINOSTAMUSTINE, A NOVEL ALKYLATING DEACETYLASE INHIBITOR, AS ADJUVANT TREATMENT IN NEWLY DIAGNOSED MGMT PROMOTER-UNMETHYLATED (UMGMT) GLIOBLASTOMA (GBM)
Neuro-Oncology2025-11-01
TIP-10. Update on GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma
Neuro-Oncology2025-11-01
P12.06.A A PHASE 1 STUDY OF TINOSTAMUSTINE, A NOVEL ALKYLATING DEACETYLASE INHIBITOR, AS ADJUVANT TREATMENT IN NEWLY DIAGNOSED MGMT PROMOTER-UNMETHYLATED GLIOBLASTOMA
Neuro-Oncology2025-10-01
Update on GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma.
Journal of Clinical Oncology2025-05-281 citations
Safety and Efficacy of Tinostamustine in a Subpopulation of Patients With Relapsed/Refractory Hodgkin Lymphoma From a Phase I Trial
Hematological Oncology2024-12-011 citations
LTBK-02. EVALUATION OF PAXALISIB IN GBM AGILE PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2024-11-012 citations
CTNI-39. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2024-11-01
OS09.7.A GBM AGILE PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GBM: RESULTS OF FIRST EXPERIMENTAL ARM, REGORAFENIB
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KS03.5.A EVALUATION OF VAL-083 IN GBM AGILE, A PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2024-10-01
P27.11.A GLOBAL EXPANSION OF GBM AGILE: A PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2024-10-01
Evaluation of VAL-083 in GBM AGILE, a phase 3 registration platform trial for newly diagnosed and recurrent glioblastoma.
Journal of Clinical Oncology2024-06-011 citations
Phase 1 dose expansion and biomarker study assessing first-in-class tumor microenvironment modulator VT1021 in patients with advanced solid tumors
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CTNI-85. GBM AGILE PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GBM: RESULTS OF FIRST EXPERIMENTAL ARM, REGORAFENIB
Neuro-Oncology2023-11-0117 citations
P11.29.B UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2023-09-01
Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study.
Journal of Clinical Oncology2023-06-013 citations
Clinical outcome of biomarker-guided therapies in adult patients with tumors of the nervous system
Neuro-Oncology Advances2023-01-0117 citations
Safety and Efficacy of Tinostamustine in Pre-Treated Patients with Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL): Early Results from an Additional Expansion Cohort of a Phase I Study
Blood2022-11-154 citations
CTNI-27. MULTI-CENTER, PHASE 2 STUDY EVALUATING THE PHARMACOKINETICS, SAFETY AND PRELIMINARY EFFICACY OF PAXALISIB IN NEWLY DIAGNOSED ADULT PATIENTS WITH UNMETHYLATED GLIOBLASTOMA (GBM)
Neuro-Oncology2022-11-011 citations
CTNI-38. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
Neuro-Oncology2022-11-01
P11.65.B GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple treatment regimens in newly diagnosed and recurrent glioblastoma
Neuro-Oncology2022-09-011 citations

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