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Recruiting
NCT07124000
DESTINY-PANTUMOUR04
Conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: AstraZeneca
Location: Research Site Birmingham Alabama
Summary
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US
Eligibility Criteria
Inclusion Criteria:
1. Adults aged ≥18 years
2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);
3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
5. Patients who are willing and able to provide a signed and dated informed consent.
Exclusion Criteria:
1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;
2. Prior T-DXd therapy;
3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
4. Patient is participating in a clinical trial at time of enrolment
Source: ClinicalTrials.gov (NCT07124000). StuddyBuddy aggregates publicly available trial information.
