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# Partial Hold on Molecular Templates Study
- URL: https://www.fdaweb.com/partial-hold-on-molecular-templates-study/
- Published: 2023-04-11T12:00:00.000Z
- Updated: 2026-09-14T18:25:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154179

FDA has placed a partial clinical hold on a Molecular Templates (MTEM) Phase 1 study of MT-0169 based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg that prompted a dose reduction from 50 mcg/kg to 5 mcg/kg last year, according to the company. “Since then, four patients have been dosed at 5 mcg/kg and three patients have been dosed at 10 mcg/kg with no cardiac adverse events noted.”

Regarding the patients dosed at 50 mcg/kg, one experienced asymptomatic Grade 2 myocarditis and the other experienced asymptomatic Grade 3 cardiomyopathy, the company says, adding that both patients had full recoveries within two months. “Under the partial clinical hold, current study participants may continue treatment, but no new patients will be enrolled until the partial hold is lifted by the FDA,” it says. “The FDA has asked MTEM to provide narratives on the two patients who experienced cardiotoxicity at 50 mcg/kg, justification for the revised dose of 5 mcg/kg, and data evaluating the clinical benefit-to-risk ratio seen with the lower doses of MT-0169, among other requests.”