Clinical Trial

Title: A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors

MOA: HER3-DXd is a HER3-directed ADC that delivers a topoisomerase I inhibitor payload (DXd) to HER3-expressing cancer cells, leading to DNA damage and tumor cell death.

Key Eligibility:

Inclusion

• Adults (≥18 years) with locally advanced unresectable or metastatic solid tumors.
• ECOG 0-1.
• At least one measurable lesion.
• Must have progressed after prior standard therapy.
• Adequate organ and bone marrow function.

Major Exclusions

• Active/interstitial lung disease (ILD) or pneumonitis.
• Symptomatic brain metastases or leptomeningeal disease.
• Prior HER3-targeted therapy.
• Prior topoisomerase I ADCs (e.g., trastuzumab deruxtecan).
• Significant uncontrolled cardiovascular or infectious disease.