Recurrent or Metastatic Solid Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGOther Drugs
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
Sponsors
Lixiaoling
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Sign the informed consent form voluntarily and agree to participate in this study. 2. Histologically or cytologically confirmed diagnosis of advanced solid tumor. 3. Age ≥ 18 years. 4. HER2 protein expression (including IHC 1+, IHC 2+, IHC 3+, or IHC 0 with ≤10% of invasive tumor cells showing incomplete/weak membrane staining). HER2 protein expression test results must be within 2 years. 5. Patients with advanced solid tumors who have failed, are intolerant to, or refuse standard therapy, and are deemed by the investigator as suitable to receive Trastuzumab Rezetecan monotherapy or combination therapy.
Exclusion criteria
1. Patients who are concurrently receiving other therapies of the same class. 2. Patients currently enrolled in another interventional clinical study. 3. Females with confirmed pregnancy or during lactation. 4. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety （Incidence of Grade ≥3 AEs） | From the first dose on Day 1 through the last dose, for up to 3 years | Safety （Incidence of Grade ≥3 AEs） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 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 | Overall Response Rate |
| PFS | From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months. | Progression Free Survival |
| OS | from the date of the first dose to the date of death for any reason, up to 3 years | Overall Survival |
| iORR | From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months. | Intracranial Objective Response Rate |
| iPFS | From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years. | Intracranial Progression-Free Survival |
Countries
China
Outcome results
None listed