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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02570308.
This is a Phase I/II clinical study of IMCgp100 in participants with advanced uveal
melanoma.
This is a Phase I/II study of IMCgp100 administered on a weekly basis with an
intra-patient escalation dosing regimen. The intra-patient escalation occurred at the
third weekly dose on Cycle 1 Day 15 (C1D15). 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 with the goal to achieve a long-term dosing regimen at a dose
higher than that identified for the weekly dosing regimen (RP2D-QW). The dose escalation
identified the intra-patient escalation regimen (RP2D-IE).
The Phase I portion of the study was a standard 3+3 dose escalation design.The
recommended Phase II dose of the intra-patient escalation dose regimen (RP2D-IE) was
identified and expansion cohorts in metastatic uveal melanoma was accrued based on prior
therapy.
Lead OrganizationImmunocore Limited
