RecruitingNCT07124000
DESTINY-PANTUMOUR04
Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study
Sponsor
AstraZeneca
Enrollment
100 participants
Start Date
Sep 18, 2025
Study Type
OBSERVATIONAL
Conditions
Liver CancerEsophageal CancerPancreatic CancerOvarian CancerCervical CancerEndometrial CancerProstate CancerSarcomaMelanomaHead and Neck CancerRenal Cell CarcinomaThyroid CancerBladder CancerTesticular CancerAnal CancerUrethral CancerSalivary Gland CancerVaginal CancerSmall Cell Lung CancerVulvar CancerGall Bladder CancerAdenocarcinoma (NOS)Gastrointestinal Stromal TumourMouth CancerNasopharangeal CancerNeuroendocrine, Gastrointestinal CancerThroat Cancer
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
Min Age: 18 YearsMax Age: 130 Years
Inclusion Criteria5
- Adults aged ≥18 years
- 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);
- A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
- HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
- Patients who are willing and able to provide a signed and dated informed consent.
Exclusion Criteria4
- 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;
- Prior T-DXd therapy;
- Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
- Patient is participating in a clinical trial at time of enrolment
Interventions
DRUGTrastuzumab deruxtecan
Trastuzumab deruxtecan monotherapy
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07124000
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