At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic uveal melanoma
- ✓HLA-A*0201 positive
- ✓ECOG Performance Status 0 or 1
- ✓Phase 2: previously treated uveal melanoma in metastatic setting
- ✕Symptomatic or untreated CNS metastases, or CNS metastases requiring corticosteroid therapy
- ✕Severe hypersensitivity reactions to biologic drugs or monoclonal antibodies
- ✕Clinically significant cardiac disease or impaired cardiac function
- ✕Active infection requiring systemic antibiotic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma
In Brief
A Phase 2 clinical trial evaluating IMCgp100 for Uveal Melanoma. Completed, enrolled 146 participants across 26 sites in 5 countries.
Detailed Summary
IMCgp100-102 is a Phase I/II study of the weekly intra-patient escalation dose regimen with IMCgp100 as a single agent in participants with metastatic uveal melanoma (mUM). According to this regimen, all participants in the trial received 2 weekly doses of IMCgp100 at a dose level below the identified weekly recommended Phase II dose (RP2D-QW) and then a dose escalation commenced at the third weekly dose at C1D15. The Phase I testing of the intra-patient escalation dosing regimen is designed to achieve a higher exposure and maximal plasma concentration of IMCgp100 after doses at Cycle 1 Day 15 (C1D15) and thereafter.
Study Details
Timeline
Interventions
Bispecific soluble HLA-A2 restricted gp100-specific T-cell receptor fused to anti-CD3