D2C7-IT
/ Istari Oncology, Duke University
- LARVOL DELTA
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December 02, 2025
An assessment of the Tumor Monorail Device (TMD) for repeated sampling as part of a trial evaluating the combination of D2C7-IT and an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery (CED) and cervical perilymphatic injections (CPLIs) of 2141-V11 in recurrent glioblastoma (rGBM) patients
(SNO 2025)
- P1 | " Eligibility include adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; KPS ≥70%, and an area of non-enhancing disease amenable for TMD implantation. Enrollment, safety and results from the repeated TMD collection will be updated."
Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor
December 02, 2025
Investigation of the combination of D2C7-IT with an Fc-engineered anti-humanCD40 monoclonal antibody (2141-V11) when administered intratumorally via convection-enhanced delivery (CED) followed by cervical perilymphatic injections (CPLIs) of 2141-V11 compared to D2C7-IT CED monotherapy in patients with recurrent glioblastoma (rGBM)
(SNO 2025)
- P1 | " Eligibility included adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; and KPS ≥70%. The addition of CPLIs of 2141-V11 post CED of D2C7-IT+2141-V11 is feasible, shows an acceptable toxicity profile, and has a survival advantage compared to D2C7-IT monotherapy."
Clinical • Monotherapy • Brain Cancer • CNS Disorders • Epilepsy • Glioblastoma • Glioma • Oncology • Solid Tumor • CD8
December 02, 2025
An assessment of the Tumor Monorail Device (TMD) for repeated sampling as part of a trial evaluating the combination of D2C7-IT and an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery (CED) and cervical perilymphatic injections (CPLIs) of 2141-V11 in recurrent glioblastoma (rGBM) patients
(SNO 2025)
- P1 | " Eligibility include adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; KPS ≥70%, and an area of non-enhancing disease amenable for TMD implantation. Enrollment, safety and results from the repeated TMD collection will be updated."
Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor
November 06, 2025
An assessment of the Tumor Monorail Device (TMD) for repeated sampling as part of a trial evaluating the combination of D2C7-IT and an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery (CED) and cervical perilymphatic injections (CPLIs) of 2141-V11 in recurrent glioblastoma (rGBM) patients
(WFNOS 2025)
- P1 | " Eligibility include adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; KPS ≥70%, and an area of non-enhancing disease amenable for TMD implantation. Enrollment, safety and results from the repeated TMD collection will be updated."
Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
November 06, 2025
Investigation of the combination of D2C7-IT with an Fc-engineered anti-humanCD40 monoclonal antibody (2141-V11) when administered intratumorally via convection-enhanced delivery (CED) followed by cervical perilymphatic injections (CPLIs) of 2141-V11 compared to D2C7-IT CED monotherapy in patients with recurrent glioblastoma (rGBM)
(WFNOS 2025)
- P1 | " Eligibility included adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; and KPS ≥70%. The addition of CPLIs of 2141-V11 post CED of D2C7-IT+2141-V11 is feasible, shows an acceptable toxicity profile, and has a survival advantage compared to D2C7-IT monotherapy."
Clinical • Monotherapy • Brain Cancer • CNS Disorders • Epilepsy • Glioblastoma • Glioma • Solid Tumor • CD8
November 06, 2025
An assessment of the Tumor Monorail Device (TMD) for repeated sampling as part of a trial evaluating the combination of D2C7-IT and an Fc-engineered anti-CD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery (CED) and cervical perilymphatic injections (CPLIs) of 2141-V11 in recurrent glioblastoma (rGBM) patients
(WFNOS 2025)
- P1 | " Eligibility include adult patients with solitary supratentorial rGBM, IDH wild-type; ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; KPS ≥70%, and an area of non-enhancing disease amenable for TMD implantation. Enrollment, safety and results from the repeated TMD collection will be updated."
Clinical • Brain Cancer • CNS Tumor • Glioblastoma
July 07, 2025
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
(clinicaltrials.gov)
- P1/2 | N=50 | Recruiting | Sponsor: Darell Bigner | Trial completion date: Feb 2028 ➔ Oct 2028 | Trial primary completion date: Feb 2026 ➔ Oct 2026
Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT
May 12, 2025
D2C7-IT With Atezolizumab for Recurrent Gliomas
(clinicaltrials.gov)
- P1 | N=18 | Active, not recruiting | Sponsor: Darell Bigner | Trial primary completion date: Dec 2025 ➔ Jun 2024
Trial primary completion date • Brain Cancer • Glioma • Malignant Glioma • Oncology • Solid Tumor
April 16, 2025
D2C7-IT With Atezolizumab for Recurrent Gliomas
(clinicaltrials.gov)
- P1 | N=18 | Active, not recruiting | Sponsor: Darell Bigner | Trial primary completion date: Dec 2024 ➔ Dec 2025
Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Solid Tumor
March 21, 2025
D2C7-IT + 2141-V11 Combination Post-resection in RGBM
(clinicaltrials.gov)
- P1 | N=46 | Recruiting | Sponsor: Darell Bigner | Not yet recruiting ➔ Recruiting
Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
March 03, 2025
Phase 1 Trial of D2C7-IT in Combination with 2141-V11 for Recurrent Malignant Glioma
(clinicaltrials.gov)
- P1 | N=90 | Recruiting | Sponsor: Darell Bigner | N=30 ➔ 90 | Trial completion date: Dec 2025 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Jun 2026
Enrollment change • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hematological Disorders • Malignant Glioma • Oncology • Solid Tumor
January 23, 2025
D2C7-IT + 2141-V11 Combination Post-resection in RGBM
(clinicaltrials.gov)
- P1 | N=46 | Not yet recruiting | Sponsor: Darell Bigner | Initiation date: Nov 2024 ➔ Mar 2025
Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
November 07, 2024
D2C7-IT in combination with an Fc-engineered anti-humanCD40 monoclonal antibody (2141-V11) administered intratumorally via convection-enhanced delivery (CED) followed by cervical perilymphatic injections (CPLIs) of 2141-V11 in patients with recurrent glioblastoma (rGBM)
(SNO 2024)
- P1 | " Eligible are adult patients with solitary supratentorial rGBM; ≥4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; and KPS ≥70%. The addition of CPLIs of 2141-V11 post CED of D2C7-IT+2141-V11 is feasible and has shown an acceptable toxicity profile. The safety and efficacy results will be updated."
Clinical • Combination therapy • Brain Cancer • CNS Disorders • CNS Tumor • Epilepsy • Glioblastoma • Oncology • Pain • Solid Tumor • Ventriculomegaly • CD8
October 04, 2024
VEGF inhibition improves immunotoxin and αCD40 antitumor response in glioblastoma models
(SITC 2024)
- "Background D2C7-immunotoxin (D2C7-IT) is a cytotoxic therapy against glioblastoma (GBM) that effectively induces tumor cell-killing by targeting wild-type epidermal growth factor receptor (EGFR) and mutant EGFR variant III (EGFRvIII) proteins, two major oncogenes in GBM...Conclusions Inhibition of VEGF improved D+C-induced antitumor responses in advanced murine gliomas by increasing CD4+ T cell and B cell recruitment. Future CD4+ T cell and B cell in vivo depletion and in vitro functional studies will confirm the mechanism behind D+C+V-mediated antitumor response."
IO biomarker • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD40 • CD8 • EGFR
October 10, 2024
D2C7-IT + 2141-V11 Combination Post-resection in rGBM
(clinicaltrials.gov)
- P1 | N=46 | Not yet recruiting | Sponsor: Darell Bigner | Phase classification: P1/2 ➔ P1
Phase classification • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
June 12, 2024
D2C7-IT + 2141-V11 Combination Post-rection in rGBM - Phase 1b
(clinicaltrials.gov)
- P1/2 | N=46 | Not yet recruiting | Sponsor: Darell Bigner
New P1/2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
April 05, 2024
D2C7 for Adult Patients With Recurrent Malignant Glioma
(clinicaltrials.gov)
- P1 | N=81 | Completed | Sponsor: Darell Bigner | Trial completion date: Oct 2022 ➔ Mar 2024
Trial completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
March 27, 2024
D2C7 for Adult Patients With Recurrent Malignant Glioma
(clinicaltrials.gov)
- P1 | N=81 | Completed | Sponsor: Darell Bigner | Active, not recruiting ➔ Completed
Trial completion • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
March 22, 2024
D2C7 for Adult Patients With Recurrent Malignant Glioma
(clinicaltrials.gov)
- P1 | N=81 | Active, not recruiting | Sponsor: Darell Bigner | Trial completion date: Jan 2024 ➔ Jul 2024
Trial completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
January 29, 2024
D2C7-IT With Atezolizumab for Recurrent Gliomas
(clinicaltrials.gov)
- P1 | N=18 | Active, not recruiting | Sponsor: Annick Desjardins, MD | Trial primary completion date: Dec 2023 ➔ Dec 2024
Combination therapy • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor
January 29, 2024
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
(clinicaltrials.gov)
- P1 | N=30 | Recruiting | Sponsor: Annick Desjardins, MD | Trial primary completion date: Dec 2023 ➔ Dec 2024
Combination therapy • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor
November 11, 2023
Phase 1/1b trial of Fc-engineered Anti-CD40 Agonist Monoclonal Antibody (2141-V11) infused with D2C7-IT in enhancing disease by Convection-Enhanced Delivery (CED) for Recurrent Malignant Glioma (rMG)
(SNO 2023)
- " Eligibility includes adult patients with solitary supratentorial rMG (WHO grade 3/4); ≥ 4weeks after chemotherapy, bevacizumab, or investigational agent; adequate organ function; and KPS ≥70%. The RP2D for intratumoral infusion of D2C7-IT+2141-V11 via CED is identified. The protocol was amended to evaluate the addition of cervical perilymphatic injections of 2141-V11 post CED of D2C7-IT+2141-V11."
IO biomarker • P1 data • Brain Cancer • CNS Disorders • CNS Tumor • Glioma • Oncology • Pain • Solid Tumor • Ventriculomegaly • CD8 • EGFR
September 21, 2023
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
(clinicaltrials.gov)
- P1/2 | N=50 | Recruiting | Sponsor: Darell Bigner | Not yet recruiting ➔ Recruiting
Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT
July 20, 2023
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
(clinicaltrials.gov)
- P1/2 | N=50 | Not yet recruiting | Sponsor: Darell Bigner | Initiation date: May 2023 ➔ Aug 2023
Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT
March 27, 2023
".@ADesjardinsMD reporting on a trial intratumoral administration of D2C7-IT, an immunotoxin-based cytotoxic therapy, targeting EGFR vIII combined with a CD40 antibody with plans to include repeated cervical perilymphatic injections of the CD40Ab #ICBTRT #AsilomarToKiawah"
(@Dukeneurosurg)
Immune Modulation • Oncology • CD40
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