Clinical trials: Diffuse Midline Glioma
Central Nervous System Neoplasms, Glioblastoma
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting…
- Conditions
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic Oligodendroglioma
- Trial name
- NCT04541082
- Testing
- ONC206
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Jazz Pharmaceuticals
Glioblastoma, Diffuse Midline Glioma
Oral ONC201 in Adult Recurrent Glioblastoma
This was a Phase 2, open-label, 6-arm, multi-center study of dordaviprone (ONC201) in patients with recurrent glioblastoma (Arms A, B, and C), H3 K27M-mutant diffuse glioma (Arm D), or diffuse midline glioma (Arms E and F).
- Conditions
- Glioblastoma, Diffuse Midline Glioma, H3 K27M Glioma, Thalamic Glioma
- Trial name
- NCT02525692
- Testing
- Dordaviprone (ONC201)
- Where
- 5 sites in United States
- Volunteers
- 84 people
- Sponsor
- Jazz Pharmaceuticals
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
- Trial name
- NCT07589257
- Testing
- VRT106 for injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
Diffuse Intrinsic Pontine Glioma, DIPG
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG).
- Conditions
- Diffuse Intrinsic Pontine Glioma, DIPG, Brain Tumor, CNS Tumor
- Trial name
- NCT07680439
- Testing
- BCB-276
- Where
- 6 sites in United States
- Volunteers
- 75 people
- Sponsor
- BrainChild Bio, Inc
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG
The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2…
- Trial name
- NCT05123534
- Testing
- SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- SonALAsense, Inc.
High Grade Glioma (III or IV), Diffuse Midline Glioma (DMG)
A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)
An Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with HGG, especially in DMG and other Recurrent HGG.
- Conditions
- High Grade Glioma (III or IV), Diffuse Midline Glioma (DMG), Glioblastoma (GBM)
- Trial name
- NCT07455045
- Testing
- FZ-AD005
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Oncology, DIPG
xPedite: A Study to Expedite DIPG and DMG Research
This study will gather data from new and existing patients with patient medical records, and patient/family/caregiver reported information to establish a clear natural history of disease suitable to serve as an external…
- Conditions
- Oncology, DIPG, DMG
- Trial name
- NCT06140719
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- xCures
Pediatric Tumor of CNS, Pediatric Tumor of Brain
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas.
- Conditions
- Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem
- Trial name
- NCT06357377
- Testing
- NEO100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neonc Technologies, Inc.
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)
This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy.
- Trial name
- KONQUER (NCT04771897)
- Testing
- BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance, BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bexion Pharmaceuticals, Inc.
H3 K27M, Glioma
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following…
- Trial name
- ACTION (NCT05580562)
- Testing
- Dordaviprone (ONC201)
- Where
- 162 sites in United States, Argentina and 16 more
- Volunteers
- 510 people
- Sponsor
- Jazz Pharmaceuticals
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Cancer, Solid Tumor
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
- Conditions
- Cancer, Solid Tumor, Solid Carcinoma, Advanced Cancer
- Trial name
- NCT05500508
- Testing
- AMXT1501, DFMO
- Where
- 7 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Aminex Therapeutics, Inc.
Diffuse Midline Glioma, H3 K27M-Mutant, Recurrent High Grade Glioma
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.
- Trial name
- NCT06305910
- Testing
- Treatment with CD200AR-L
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- OX2 Therapeutics
Solid Tumors
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with…
- Trial name
- NCT02711137
- Testing
- INCB057643, Gemcitabine, Paclitaxel
- Where
- 18 sites in United States, Belgium and 1 more
- Volunteers
- 137 people
- Sponsor
- Incyte Corporation
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma…
- Trial name
- NCT05518838
- Testing
- OKN-007
- Where
- 9 sites in United States
- Sponsor
- Oblato, Inc.
Gastrointestinal Stromal Tumors, GIST
A Drug-drug Interaction Study of Avapritinib and Midazolam
The purpose of this study is to investigate the effect of multiple dosing of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST)…
- Conditions
- Gastrointestinal Stromal Tumors, GIST, Non-resectable Advanced Solid Tumors, Recurrent or Unresectable Central Nervous System (CNS) Tumors
- Trial name
- NCT04908176
- Testing
- Avapritinib, midazolam
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Blueprint Medicines Corporation
High Grade Glioma, Astrocytoma
Study of Olutasidenib and Temozolomide in HGG
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
- Conditions
- High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV
- Trial name
- NCT06161974
- Testing
- Olutasidenib + TMZ
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 60 people
- Sponsor
- Rigel Pharmaceuticals
Diffuse Midline Glioma (DMG), Diffuse Intrinsic Pontine Glioma (DIPG)
Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response
Open-label, dose-escalating, Phase 1/2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic…
- Conditions
- Diffuse Midline Glioma (DMG), Diffuse Intrinsic Pontine Glioma (DIPG), Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma
- Trial name
- TIGER-1 (NCT07767110)
- Testing
- LSAM-Cisplatin
- Volunteers
- 20 people
- Sponsor
- NanOlogy, LLC