Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
Status:
Withdrawn
Trial end date:
2023-05-30
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety,
tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in
patients with advanced solid tumors with confirmed homozygous CDKN2A loss and WT TP53 who
have progressed on or are refractory to prior PD-1/PD-L1 inhibitor therapy and who, in the
opinion of the Investigator, are unlikely to tolerate or derive clinically meaningful benefit
from other therapy.
This study will determine the recommended dose of milademetan when given in combination with
atezolizumab (the combination RP2D) using a dose de-escalation safety assessment cohort
(Phase 1b).
Following identification of the combination RP2D, the safety profile and preliminary
anti-tumor activity of the combination RP2D will be evaluated in a larger population in a
dose expansion cohort (Phase 2).