D2C7-IT With Atezolizumab for Recurrent Gliomas
NCT04160494 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-05-11
Summary
This is a phase 1 study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Conditions
- Malignant Glioma
Interventions
- DRUG
-
D2C7-IT (6920 ng/mL via convection-enhanced delivery)
dual-specific mAB
- DRUG
-
Atezolizumab (1200 mg every three weeks)
programmed cell death ligand 1 (PD-L1) blocking antibody
- DRUG
-
D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)
dual-specific mAB
Sponsors & Collaborators
-
Istari Oncology, Inc.
collaborator INDUSTRY -
National Cancer Institute (NCI)
collaborator NIH -
Genentech, Inc.
collaborator INDUSTRY -
Darell Bigner
lead OTHER
Principal Investigators
-
Daniel Landi, MD · Duke University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-25
- Primary Completion
- 2024-06-28
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma
NCT02942264 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
NCT00916409 ·Status: COMPLETED ·Phase: PHASE3
-
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme
NCT04002804 ·Status: TERMINATED ·Phase: PHASE1
-
Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients
NCT02649582 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
NCT00003464 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
NCT00611325 ·Status: COMPLETED ·Phase: PHASE2
-
Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma
NCT01004874 ·Status: COMPLETED ·Phase: PHASE2
-
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
NCT05039281 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma
NCT00734864 ·Status: WITHDRAWN ·Phase: PHASE1
-
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
NCT04201873 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma
NCT05700955 ·Status: UNKNOWN ·Phase: PHASE1
-
Nivolumab With DC Vaccines for Recurrent Brain Tumors
NCT02529072 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma
NCT02546102 ·Status: SUSPENDED ·Phase: PHASE3
-
Prolonged Daily Temozolomide for Low-Grade Glioma
NCT00165360 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
NCT02805179 ·Status: COMPLETED ·Phase: PHASE2
-
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT07027748 ·Status: RECRUITING ·Phase: PHASE1
-
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
NCT00004204 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme
NCT01822275 ·Status: TERMINATED ·Phase: PHASE2
-
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
NCT00114309 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma
NCT00683761 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
NCT00003466 ·Status: COMPLETED ·Phase: PHASE2
-
Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
NCT03174197 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
NCT06157541 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma
NCT03389230 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM
NCT04003649 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1