At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
ARG1-18,19,20biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
In Brief
A Phase 1 clinical trial evaluating ARG1-18,19,20 for Non Small Cell Lung Cancer and 7 related conditions. Completed, enrolled 13 participants across 1 site.
Detailed Summary
In this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors. Patients will be treated with an ARG1 vaccine every third week for 45 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer, Urothelial Carcinoma, Malignant Melanoma, Ovarian Cancer, Colorectal Cancer, Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Metastatic Cancer
CountriesDenmark
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartDec 2018
Primary CompletionJan 2022
TodayJul 2026
First PostedSep 28, 2018
Enrollment StartDec 17, 2018
Primary CompletionJan 19, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.8 years ago
Interventions
ARG1-18,19,20biological
300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide