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.
Study Type
OBSERVATIONAL
Enrollment
30
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.
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
BeidahuangGGH
Harbin, China
Safety （Incidence of Grade ≥3 AEs）
Safety （Incidence of Grade ≥3 AEs）
Time frame: From the first dose on Day 1 through the last dose, for up to 3 years
ORR
Overall Response Rate
Time frame: 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
Progression Free Survival
Time frame: From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months.
OS
Overall Survival
Time frame: from the date of the first dose to the date of death for any reason, up to 3 years
iORR
Intracranial Objective Response Rate
Time frame: 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
Time frame: From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years.
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