Milademetan is currently being investigated in liposarcomas (LPS) and a broad array of solid tumors characterized by MDM2 dependence and wildtype TP53.
MANTRA is an ongoing Phase 3 study of milademetan in patients with DD LPS who have progressed on prior therapy.
Overview
Endpoints
*With or without a well-differentiated component.
DCR, disease control rate; DOR, duration of response; IV, intravenous; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; QD 3/14, once daily on days 1-3 every 14 days; Q3W, every 3 weeks.
MANTRA-2 is an ongoing Phase 2, multicenter, single-arm, open-label, basket study in patients TP53 wildtype advanced solid tumors with MDM2 gene amplification.
Overview
CN, copy number; NGS, next-generation sequencing; QD 3/14, once daily on days 1-3 every 14 days.
MANTRA-4 is a Phase 1/2 study evaluating the safety and efficacy of milademetan + anti-PD-L1 antibody, atezolizumab, in patients with CDKN2A loss and other p53 wildtype advanced cancers.
Rain will evaluate the safety and efficacy of inhibition of the MDM2-p53 interaction with milademetan and PD-L1 inhibition with atezolizumab in patients with CDKN2A loss and WT TP53 advanced solid tumors.
Atezolizumab is utilized in this trial per a clinical supply agreement with Roche.
DD, dedifferentiated; DLT, dose-limiting toxicity; Q4W, every 4 weeks; QD 3/14, once daily on days 1-3 every 14 days; RP2D, recommended Phase 2 dose.
1. Data on file. Rain Oncology, 2023.
