A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
- Conditions
- Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
- Registration Number
- NCT06271837
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 175
Inclusion Criteria:<br><br> - At least 18 years of age.<br><br> - Locally advanced, unresectable, or metastatic solid tumors based on most recent<br> imaging.<br><br> - HER2 expression.<br><br> - ECOG performance status of 0-1.<br><br> - Must provide an adequate FFPE tumor sample to centrally determine HER2 status and<br> other correlatives.<br><br> - Has measurable target disease assessed by the investigator based on RECIST 1.1.<br><br> - Adequate organ function and bone marrow within 14 days before enrollment.<br><br> - Contraceptive use by males or females should be consistent with local regulations<br> regarding the methods of contraception for those participating in clinical studies.<br><br> - Capable of giving signed informed consent.<br><br> - Provision of signed and dated written ICF prior to mandatory study-specific<br> procedures, sampling, or analyses.<br><br> - Evidence of post-menopausal status or negative serum pregnancy test for females of<br> childbearing potential who are sexually active with a non-sterilized male partner.<br><br>Exclusion Criteria:<br><br> - Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric<br> body or gastroesophageal junction.<br><br> - Has substance abuse or any other medical conditions that may interfere with the<br> patient's participation in the clinical study or evaluation of the clinical study<br> results.<br><br> - A pleural effusion, ascites or pericardial effusion that requires drainage,<br> peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.<br><br> - History of another primary malignancy except for malignancy treated with curative<br> intent with no known active disease within 3 years before the first dose of study<br> intervention and of low potential risk for recurrence. Exceptions include adequately<br> resected non melanoma skin cancer, curatively treated in situ disease, or other<br> solid tumors curatively treated.<br><br> - Has unresolved toxicities from previous anti cancer therapy.<br><br> - Has any spinal cord compression, leptomeningeal disease, or clinically active CNS<br> metastases.<br><br> - Uncontrolled infection requiring IV injection of antibiotics, antivirals, or<br> antifungals, or active infection including tuberculosis.<br><br> - Active primary immunodeficiency, known uncontrolled active HIV infection, or active<br> Hepatitis B or C infection.<br><br> - Protocol-defined inadequate cardiac function.<br><br> - History of (non-infectious) ILD/pneumonitis that required steroids, has current<br> ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at<br> screening.<br><br> - Has a concomitant medical condition that would increase the risk of toxicity in the<br> opinion of the investigator.<br><br> - Anti cancer chemotherapy without an adequate treatment washout period prior to<br> enrollment.<br><br> - Major surgical procedure (excluding placement of vascular access) or significant<br> traumatic injury within 4 weeks of the first dose of study intervention or an<br> anticipated need for major surgery during the study.<br><br> - Known allergy or hypersensitivity to study treatment or any excipients of the<br> product or other mAbs.<br><br> - Involvement in the planning and/or conduct of the study.<br><br> - Judgment by the investigator that the patient should not participate in the study if<br> the patient is unlikely to comply with study procedures, restrictions, and<br> requirements.<br><br> - Previous enrollment in the present study. Concurrent enrollment in another<br> therapeutic clinical study (excluding observational studies).<br><br> - For females only: Currently pregnant or breast feeding, or who are planning to<br> become pregnant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method Duration of Response (DoR);Disease control rate (DCR);Confirmed best objective response (BOR);Progression-free survival (PFS);Overall survival (OS);Occurrence of adverse events (AEs) and serious adverse events (SAEs);Pharmacokinetics (PK) of T-DXd;Immunogenicity of T-DXd