NEW YORK – Rain Therapeutics said on Wednesday that Caris Life Sciences will provide patient referral services for a Phase II study of its MDM2 inhibitor RAIN-32.
Caris will use its molecular intelligence trials platform, which includes whole-exome and transcriptome sequencing services, to test patients with solid tumors to assess if they have MDM2 amplifications and normal p53 status and refer them to the Phase II study. Rain expects to begin the tumor-agnostic basket trial in the second half of 2021.
In a Phase I study, RAIN-32 showed activity in previously treated patients with advanced liposarcoma and MDM2-amplified solid tumors. In patients with liposarcoma, the disease control rate was 58.5 percent, and among patients with non-liposarcoma solid tumors the disease control rate was 32.4 percent.
The Newark, California-based firm licensed RAIN-32 worldwide from Daiichi Sankyo in September. Rain is also exploring the drug's activity in an MDM2-amplified subtype of liposarcoma, and it plans to begin a Phase III trial in liposarcoma this year. Rain also is planning a Phase II trial of RAIN-32 in intimal sarcoma.