A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochr… (NCT04187404) | Clinical Trial Compass
TerminatedPhase 1/2
A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma
Stopped: Strategic decision
United States, Denmark, France70 participantsStarted 2020-07-23
Plain-language summary
This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. For inclusion in Cohort 1 patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A.
✓. For inclusion in Cohorts 2A and 2B patients should have histologically confirmed (at primary diagnosis) unresectable locally advanced or metastatic adrenocortical carcinoma.
✓. For inclusion in Cohorts 3A and 3B patients should have histologically confirmed (at primary diagnosis) unresectable malignant (defined as metastatic disease, i.e. presence of chromaffin tissue in non-chromaffin organs) pheochromocytoma/paraganglioma, and RECIST defined progression should have been documented during a maximum of an 18-months period.
✓. Patients with an age ≥ 18 years old.
✓. Patients who are human leukocyte antigen (HLA)-A2 positive.
✓. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
✓. Patients with a life expectancy \> 4 months as judged by their treating physician.
✓. Patients with at least one measurable lesion according to RECIST 1.1.
Exclusion criteria
✕. Patients treated with dexamethasone \> 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2401 administration, unless required to treat an adverse event.
✕. Patients with prior treatment with immune check-point inhibitors
✕. Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2401 administration.
✕. Patients with an initial diagnosis of ACC less than 9 months from start of screening part 2.
✕. Patients with ACC and any individual lesion according to RECIST 1.1 having a maximum diameter of more than 125 mm; irrespective if the lesion is proposed as a target lesion, or not, according to RECIST 1.1.
✕. Patients with ACC with more than three organs involved by disease, combined with unresectable primary tumor.
✕. Patients with ACC and uncontrolled hormonal secretion (according to the judgement of the treating physician).