Phase 12 Study of Oral REC-1245 for Unresectable, Locally Advanced, or Metastatic Solid Tumors and Lymphomas

What this Trial Is About

Researchers are evaluating REC-1245, an oral drug, in participants aged 12 and older with unresectable, locally advanced, or metastatic solid tumors, including some relapsed or refractory lymphomas. This open-label, multi-center study aims to assess the safety, tolerability, how the drug is processed in the body pharmacokinetics, and preliminary activity of REC-1245. The study includes both Phase 1 and Phase 2 portions, focusing on identifying appropriate dosing and measuring treatment effects over time. Participants will receive REC-1245 once daily by mouth for up to two years. The study has several groups, including dose-finding and multiple cohorts in Phase 1b and Phase 2, each receiving experimental doses of REC-1245. There is no use of placebo or blinding, and the treatment schedule is designed to monitor responses and side effects closely throughout the study duration. During the study, participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor size, and evaluations of side effects from the start of treatment until up to 30 days after the last dose. Researchers will track key outcomes such as dose limiting toxicities, adverse events, and tumor responses over the treatment period of up to approximately 24 months. Safety and drug levels in the blood will be monitored intensively in early phases to guide dosing and evaluate tolerability.

A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer