NEW YORK – Rain Therapeutics said on Friday that it has dosed its first patients in a Phase II basket trial evaluating milademetan for MDM2-amplified advanced solid tumors.
The trial, dubbed MANTRA-2, is designed to assess the safety and preliminary efficacy of milademetan for patients with advanced solid tumors that harbor wild-type p53 and a minimum MDM2 gene copy number. Rain expects to enroll roughly 65 patients, all of whom are refractory or intolerant to standard treatment.
The trial's primary endpoint is objective response rate, and the secondary endpoints include duration of response, disease control rate, progression-free survival, and growth modulation index. The Newark, California-based firm expects to report interim data from the trial during the second half of 2022.
"The MANTRA-2 study reflects our precision oncology focus to base our development strategy on the underlying biological drivers in cancer, now across a tumor-agnostic clinical trial," Avanish Vellanki, Rain's CEO, said in a statement. "We have also identified a level of gene amplification of MDM2 that we believe will select for patients most likely to benefit."
Recently, Rain also announced that milademetan demonstrated encouraging preliminary efficacy in a small initial study of certain MDM2-amplified sarcoma patients.