A Real-World Study of Trastuzumab Rezetecan in HER2+ Solid Tumors

Lixiaoling

Status: Active, not recruiting

Conditions: Recurrent or Metastatic Solid Tumors

Treatments: Drug: Other Drugs; Drug: Trastuzumab Rezetecan

Study type: Observational

Funder types: Other

Identifiers

NCT07387874

SHR-A1811-HLJ-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Treatment arm

Description:

Trastuzumab Rezetecan: ± Other Drugs

Treatment:

Drug: Trastuzumab Rezetecan

Drug: Other Drugs