FDA Lifts Partial Clinical Hold on Trial Examining CDK8/CDK19 Inhibitor RVU120 in AML, MDS
The FDA lifted a partial clinical hold on a phase 1b trial for RVU120 in AML and MDS patients, following a serious adverse event. Enrollment resumes with a revised 75-mg dose protocol. RVU120, a CDK8/CDK19 inhibitor, showed promise in preclinical models. The trial aims to assess safety, efficacy, and pharmacokinetics, with initial data indicating varied patient responses.
Related Clinical Trials
Reference News
FDA Lifts Partial Clinical Hold on Trial Examining CDK8/CDK19 Inhibitor RVU120 in AML, MDS
The FDA lifted a partial clinical hold on a phase 1b trial for RVU120 in AML and MDS patients, following a serious adverse event. Enrollment resumes with a revised 75-mg dose protocol. RVU120, a CDK8/CDK19 inhibitor, showed promise in preclinical models. The trial aims to assess safety, efficacy, and pharmacokinetics, with initial data indicating varied patient responses.