A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
Phase 2
Active, not recruiting
NCT04639219
| Condition | Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast |
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| Phase | Phase 2 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 102 participants |
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| Interventions | Trastuzumab deruxtecan |
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| Start date | Dec 30, 2020 |
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| Completion date | Jan 25, 2023 |
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| Results posted | Feb 15, 2024 |
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Summary
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.
Confirmed Overall Response Rate (ORR) as Per RECIST v1.1 Using Independent Central Review (ICR)
Tumor scans performed at screening,then every 6 weeks (q6w) +/- 1 week relative to date of first treatment administration until RECIST v1.1 objective PD, withdrawal of consent, or death by any cause, up to DCO date of 25 Jan 2023 (approximately 24 months) · percentage of participants
| T-DXd | 29.4 percentage of participants |
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Open in BENITIONS
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