FDA Lifts Hold on MediLink’s Phase 1 Trial for HER3-Targeting Cancer Drug

The FDA has lifted a partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC), allowing the trial to resume with adjusted dose levels. The decision follows MediLink’s submission of a complete response addressing FDA concerns regarding potential safety risks at higher doses. The trial will focus on dose levels not exceeding 3 mg/kg, where the treatment has shown a manageable safety profile.

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