A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2023-06-29
Target enrollment:
Participant gender:
Summary
The primary goal of this Phase 1 study is to characterize the safety and tolerability of
INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on
either every two week or every four week schedules of administration among patients with
solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012
will also be assessed.
The purpose of Amendment 5 is to obtain additional safety experience at the newly defined
recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer,
specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor
agnostic cohort.