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XMT-1522 · 1 trial · 3 indications
Evaluate adverse events and use of concomitant medication use after XMT-1522 doses
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Confirmation | EXPERIMENTAL | XMT-1522 treatment will administered in groups of patients who will receive doses that increase over time. Once the maximum tolerated dose or recommended Phase 2 dose is achieved, new groups of patients will receive XMT-1522 at this fixed dose. |
| Name | Type | Description |
|---|---|---|
| XMT-1522 | DRUG | one intravenous dose administered in-clinic every 21 days |
Inclusion Criteria: * Able and willing to give informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease via RECIST * Resolution of all toxic side effects from prior oncology treatments * Adequate organ function as measured by various blood param...
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XMT-1522 is an investigational therapy studied in advanced breast cancer, specifically in patients whose tumors express HER2. It was also evaluated in advanced nonsmall cell lung cancer and advanced gastric cancer. It is a small molecule developed by Day One Biopharmaceuticals and has been tested in a single Phase 1 trial.
XMT-1522 is being developed by Day One Biopharmaceuticals, Inc., which trades under the ticker DAWN. The company is the sponsor of the clinical program for this asset.
XMT-1522 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. The single Phase 1 trial, NCT02952729, has been completed, and no trials are currently active.
XMT-1522 was studied in one Phase 1 trial, NCT02952729, titled Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2. The trial enrolled 120 patients across the United States and has been completed. It was an uncontrolled, non-randomized study in adults.
Yes, XMT-1522 is a biomarker-selected therapy. The Phase 1 trial NCT02952729 enrolled patients with advanced breast cancer expressing HER2, meaning eligibility required the presence of this biomarker. The study also included patients with advanced nonsmall cell lung cancer and advanced gastric cancer.