Study of Biological Effect in Tumor Samples from Clinical Trial Patients Treated with Ds8201
- Conditions
- Patients diagnosed with advanced or metastatic cancer treated with Trastuzumab Deruxtecan in the context of a clinical trial/expanded access/ compassionate use or standard treatment, irrespective of histologic type.Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508830-33-00
- Lead Sponsor
- Solti Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Women and men =18 years old who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan (T-DXd; DS-8201a) as a treatment for metastatic/advanced cancer., The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart., Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content.a.Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases. b.Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable., Patients included before starting experimental treatment must be able and willing to provide blood sample(s).
Not applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method