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

Trastuzumab Rezetecan Alone or in Combination for the Treatment of Patients With Recurrent or Metastatic Malignant Solid Tumors Expressing HER-2 Protein: A Single-Center, Real-World Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent or Metastatic Solid Tumors
• Intervention / Treatment: Drug: Trastuzumab Rezetecan; Drug: Other Drugs

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• China
  • Harbin, China
    • BeidahuangGGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment arm; Trastuzumab Rezetecan: ± Other Drugs

Drug: Trastuzumab Rezetecan; 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.; Drug: Other 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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）	Safety（ Incidence of AEs and SAEs）	From the first dose on Day 1 through the last dose, for up to 3 years

Collaborators and Investigators

• Sponsor: Lixiaoling

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: SHR-A1811-HLJ-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No