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Rain Therapeutics Doses First Patient in Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)

The interventional, multicenter, open-label Phase 2 basket trial will evaluate the safety and efficacy of milademetan in patients with MDM2-amplified advanced solid tumors

Excerpt from the Press Release:

NEWARK, Calif., Nov. 19, 2021 (GLOBE NEWSWIRE) — Rain Therapeutics Inc. (NasdaqGS: RAIN), (“Rain”), a late-stage company developing precision oncology therapeutics, today announced that the first patient has been dosed in the multicenter, single arm, open-label, Phase 2 basket trial evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of MDM2-amplified advanced solid tumors.

“The Rain team has worked extraordinarily hard to now commence our second clinical trial for milademetan,” said Avanish Vellanki, chief executive officer of Rain Therapeutics. “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. We have also identified a level of gene amplification of MDM2 that we believe will select for patients most likely to benefit.”

Richard Bryce, MBChB, chief medical officer of Rain Therapeutics continued, “the opening of our Phase 2 basket trial is a significant step forward in leveraging the safety profile of milademetan for patients with advanced tumors that exhibit wild-type p53 and amplified MDM2 who do not respond, or stop responding, to standard-of-care therapy.”

The MANTRA-2 trial is designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy and that exhibit wild-type p53 and a prespecified minimum MDM2 gene copy number. Approximately 65 patients are anticipated to be enrolled to receive milademetan. The primary endpoint of the trial is objective response rate as measured by RECIST criteria. Secondary endpoints include duration of response, disease control rate progression-free survival by investigator assessment, overall survival and, and growth modulation index. An interim analysis from MANTRA-2 is anticipated in the second half of 2022.

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