Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
ConditionGlioma, Malignant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDarell Bigner
About this trial
This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subgroup #2: Histopathologically confirmed recurrent supratentorial WHO grade 3 or 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma)
Subgroup #3: Histopathologically confirmed recurrent supratentorial WHO grade 4 malignant glioma (high grade glioma with molecular features of glioblastoma will be eligible under WHO grade 4 malignant glioma) and found amenable for Tumor Monorail Device (TMD) implantation as per the treating neurosurgeon
Non-childbearing potential (i.e.) not sexually active, physiologically incapable of becoming pregnant, including people who are post-menopausal or surgically sterile. Surgically sterile people are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation or have had a vasectomy. Postmenopausal for purposes of this study is defined as 1 year without menses.; or
Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide.
Disqualifiers
Patients who are pregnant or breastfeeding/chestfeeding
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
Patients with known immunosuppressive disease or known human immunodeficiency virus infection
Trial design
Design model
Parallel
Treatments tested in this trial
D2C7-IT
DrugD2C7-IT intratumoral infusion
2141-V11
Drug2141-11 intratumoral infusion
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: D2C7-IT + 2141-V11Experimental treatment 2 interventions
Group B: D2C7-IT + 2141-V11 and Tumor Monorail Device (TMD) PlacementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients with dose-limiting toxicity (DLT) within each dose level
DLTs are defined as any of the following events that are at least possibly, probably, or definitely attributable to study treatment (2141-V11 or the combination of D2C7-IT and 2141-V11) during dose escalation. As the optimal dose of D2C7-IT in monotherapy has been well established, only toxicity starting or increasing in grade at any time after the start of 2141-V11 will be considered for DLT definition.
Time frame
28 days after catheter removal2
Proportion of patients with unacceptable toxicity resulting from injections of 2141-V11 in the CPL area ipsilateral to the tumor
For the purpose of monitoring adverse events occurring with perilymphatic injections of 2141-V11, we will define an unacceptable toxicity as any adverse event that satisfies the definition of DLT.
Time frame
28 days after catheter removal3
The proportion of patients with Tumor Monorail Device (TMD)-related unacceptable adverse event
Unacceptable adverse events following TMD placement are defined as follows * Cerebral edema (grade 3 or higher) due to device implantation * New neurological symptoms (grade 3 or higher) that do not resolve within 2 weeks and not due to tumor progression * Device-related infection (grade 3 or higher) * Intracranial hemorrhage (grade 3 or higher) * Tumor mis-migration (extracranial extension)
Time frame
14 days following TMD placementSponsors and contacts
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Source ClinicalTrials.gov