OncoMatch/Clinical Trials/NCT05734560
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
Is NCT05734560 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including D2C7-IT and 2141-V11 for newly diagnosed mgmt unmethylated glioblastoma.
Treatment: D2C7-IT · 2141-V11 — The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Required: MGMT unmethylated
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
WHO grade 4
Prior therapy
Must have received: radiation therapy — concomitant with TMZ
completed standard of care radiation therapy (typically 59.4-60 Gy over approximately 6 weeks duration if under 65 years old and a minimum of 40 Gy over 3 weeks duration if 65 years or older) in combination with TMZ and 2 cycles of post-radiation, adjuvant TMZ
Must have received: temozolomide (temozolomide) — concomitant and adjuvant
completed standard of care radiation therapy ... in combination with TMZ and 2 cycles of post-radiation, adjuvant TMZ
Cannot have received: other therapeutic interventions for newly diagnosed GBM
Exception: surgical resection and standard of care concomitant radiation therapy and TMZ and 2 cycles of post-radiation, adjuvant TMZ
Patients who previously received other therapeutic interventions for newly diagnosed GBM with the exception of surgical resection and standard of care concomitant radiation therapy and TMZ and 2 cycles of post-radiation, adjuvant TMZ for their brain tumor
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dl; Platelet count ≥ 100,000/µL unsupported (≥ 125,000/µL for biopsy/catheter insertion); Neutrophil count ≥ 1000
Kidney function
Creatinine ≤ 1.5 x normal range
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's Syndrome); AST/ALT ≤ 2.5 x ULN
Hemoglobin ≥ 9 g/dl prior to catheter placement; Platelet count ≥ 100,000/µL unsupported...platelet count ≥ 125,000/µl is required for the patient to undergo biopsy and catheter insertion...Neutrophil count ≥ 1000 prior to catheter placement; Creatinine ≤ 1.5 x normal range prior to catheter placement; Total bilirubin ≤ 1.5 x ULN...AST/ALT ≤ 2.5 x ULN; PT and PTT ≤ 1.2 x normal prior to biopsy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Medical Center · Durham, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05734560 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior other therapeutic interventions for newly diagnosed GBM disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Does this trial require MGMT?
Yes, MGMT unmethylated is a required biomarker for enrollment.
What disease stage is eligible?
Stage WHO GRADE 4 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages