CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 84 enrolled
Drug / intervention
IMCgp100drug
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.

Search/NCT01211262
NCT01211262Phase 1Completed
CompareCT.gov

A Phase 1, Open Label, Dose Finding Study to Assess the Safety and Tolerability of IMCgp100, a Monoclonal T Cell Receptor Anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma

Immunocore Ltd·interventional·Posted Sep 29, 2010·Updated Jul 8, 2020

In Brief

A Phase 1 clinical trial evaluating IMCgp100 for Malignant Melanoma. Completed, enrolled 84 participants across 9 sites in 2 countries.

Detailed Summary

IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial is designed to establish the level of drug that can be given to a patient that is tolerable. It also designed to establish the best dosing schedule for the drug and to look for signals that the drug is working as intended.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2010
Enrollment StartSep 28, 2010
Primary CompletionFeb 16, 2016
Study CompletionFeb 16, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 15.8 years ago

Interventions

IMCgp100drug

For each arm, the study will be divided into two parts: In part 1, dose escalation, the MTD or RP2D for each dosing regimen will be established. In part 2, dose expansion, a cohort of participants will be treated at the RP2D or MTD.