A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations - DPT01

Exclusion Criteria

• • HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
• • HER2 mutant NSCLC.
• • Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
• • History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
• • Corrected QT interval by Fridericia's formula (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG.
• • Lung-specific intercurrent clinically significant severe illnesses.
• • History of active primary immunodeficiency, known HIV, active HBV or HCV infection
• • Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
• • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
• • Has spinal cord compression or clinically active central nervous system metastases.