NEW YORK – Hutchison China MediTech (HutchMed) on Monday said it has started two international Phase I trials of its small molecule inhibitor of IDH1/2 mutations, called HMPL-306, in advanced solid tumors and hematologic malignancies.
The Hong Kong-headquartered pharmaceutical firm said that it dosed the first international patient with HMPL-306 last week in the clinical trial program, which will be led by MD Anderson Cancer Center. Although a Phase I trial of the drug already started in China in the second half of 2020, these dose escalation and expansion trials of HMPL-306 will now also enroll patients with solid and hematologic cancers at sites in the US and Europe and evaluate the drug's safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy.
"This new program is a demonstration of HutchMed's accelerating and expanding global clinical development presence," the company said in a statement.
The solid tumor trial is enrolling patients with gliomas, chondrosarcomas, and cholangiocarcinomas, among other cancer types. The hematologic malignancy trial is focusing on enrolling patients with advanced, relapsed, refractory, or resistant cancers. Patients will have to have cancers characterized by IDH1 or IDH2 mutations.
IDH1/2 mutations occur in a variety of solid and blood cancers, notably in 20 percent of acute myeloid leukemias, in 60 percent to 80 percent of gliomas and glioblastomas, and in 20 percent to 30 percent of intrahepatic cholangiocarcinomas. Although in the US there are available treatments that target either IDH1 or IDH2 mutations in AML patients, there isn't an approved drug that inhibits both. By targeting both isoforms of IDH, "HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation and may address acquired resistance to IDH inhibition through isoform switching," HutchMed said in a statement.