Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To Observe and Evaluate the Safety Profile of Trastuzumab Rezetecan Alone or in Combination in Patients with HER-2 Protein-Expressing Recurrent or Metastatic Malignant Solid Tumors in a Real-World Setting.
Trastuzumab Rezetecan specifically binds to HER2 on the surface of tumor cells. The conjugate is subsequently internalized into the cells and transported to lysosomes, where the linker is cleaved by cathepsins to release the free toxin SHR169265. This payload inhibits the activity of DNA topoisomerase I, thereby inducing apoptosis in tumor cells. Owing to the high membrane permeability of SHR169265, a bystander killing effect is also observed: after being released inside tumor cells, it can diffuse into neighboring cells, exerting cytotoxic effects even on HER2-negative cells. This study aims to evaluate the efficacy and safety of Trastuzumab Rezetecan, either as monotherapy or in combination regimens, in patients with HER2-expressing recurrent or metastatic malignant solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Trastuzumab Rezetecan: ± Other Drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Rezetecan | Drug | Trastuzumab Rezetecan: 4.8 mg/kg, administered every 21 days as one treatment cycle. Patients will receive treatment according to the investigator-defined regimen containing Trastuzumab Rezetecan until disease progression (PD), intolerable toxicity, patient-initiated withdrawal, or the occurrence of other medical events determined by the physician that make the combination therapy unsuitable for continuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety （Incidence of Grade ≥3 AEs） | Safety （Incidence of Grade ≥3 AEs） | From the first dose on Day 1 through the last dose, for up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months |
| PFS |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between HER2 Expression Levels and Safety and Efficacy | Safety and Efficacy According to HER2 Expression Levels (IHC 1+, IHC 2+, IHC 3+, or IHC 0 with ≤10% of Invasive Tumor Cells Showing Incomplete/Weak Membrane Staining) | from the first drug administration up to 3 years |
| Safety（ Incidence of AEs and SAEs） |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Based on investigator assessment, patients with HER-2 protein-expressing recurrent or metastatic malignant solid tumors are eligible to receive trastuzumab, either as monotherapy or in combination therapy.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeidahuangGGH | Harbin | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Other Drugs | Drug | The administration regimens for Trastuzumab Rezetecan include, but are not limited to: Combination with immune checkpoint inhibitors ± other agents Combination with targeted agents ± other agents Combination with radiotherapy ± other agents |
|
Progression Free Survival
| From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months. |
| OS | Overall Survival | from the date of the first dose to the date of death for any reason, up to 3 years |
| iORR | Intracranial Objective Response Rate | From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months. |
| iPFS | Intracranial Progression-Free Survival | From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years. |
Safety（ Incidence of AEs and SAEs） |
| From the first dose on Day 1 through the last dose, for up to 3 years |