Phase I Study of TAK-243, an Ubiquitin Activating Enzyme Inhibitor, for Adults with Advanced Solid Tumors and Lymphomas

What this Trial Is About

Researchers are evaluating TAK-243, a drug that inhibits the ubiquitin-activating enzyme, in patients with advanced or metastatic solid tumors and lymphomas. This phase I trial aims to determine the safety, tolerability, and best dose of TAK-243 given intravenously. The study also explores pharmacokinetics, effects on tumor markers, and preliminary anti-tumor activity and survival outcomes. TAK-243 targets an enzyme that is more active in cancer cells, potentially affecting tumor growth and survival. Participants are assigned to one of two treatment arms Arm A receives TAK-243 intravenously on days 1, 4, 8, and 11 of a 21-day cycle, while Arm B receives the drug once weekly on days 1, 8, and 15 of a 28-day cycle. Patients undergo biopsies during the study and have imaging tests including CT and MRI scans as well as blood collection. Echocardiograms may be performed if clinically needed. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients have regular assessments including tumor biopsies, imaging scans, and blood tests to monitor treatment effects and safety. Researchers measure the maximum tolerated dose, recommended phase II dose, and incidence of dose-limiting toxicities within the first treatment cycle. Follow-up occurs for 30 days after treatment ends to observe pharmacodynamics and tumor response. The total duration of participation depends on treatment cycles and response.

Studying TAK-243 in Patients With Advanced Cancer