A study to investigate anti-tumor activity and safety of trastuzumab deruxtecan in patients with solid tumors carrying specific HER2 mutations.

Phase 1

• Conditions: Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-516158-22-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Adults =18 years old. Other age restrictions may apply as per local regulations., Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options., Prior HER2 targeted therapy is permitted., All patients must provide an FFPE tumor sample for retrospective central HER2 testing., LVEF =50%, ECOG 0-1

Exclusion Criteria

HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma., HER2 mutant NSCLC., History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified