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

NCT07387874 | Active Not Recruiting

• 1 other identifier: SHR-A1811-HLJ-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• PFS

  From the first vaccination to the first recorded disease progression or death, the assessment period was up to 36 months.

• OS

  from the date of the first dose to the date of death for any reason, up to 3 years

• iORR

  From the first dose until the occurrence of intracranial progression or death (whichever occurs first), assessed up to 6 months.

• iPFS

  From the date of the first dose to the date of the first documented intracranial progression, assessed for up to 3 years.

Other Outcomes (2)

• Correlation between HER2 Expression Levels and Safety and Efficacy

  from the first drug administration 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

Study Arms (1)

Treatment arm

Trastuzumab Rezetecan: ± Other Drugs

Drug: Trastuzumab Rezetecan; Drug: Other Drugs

Interventions

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.

Treatment arm

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

Treatment arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Sign the informed consent form voluntarily and agree to participate in this study.
• Histologically or cytologically confirmed diagnosis of advanced solid tumor.
• Age ≥ 18 years.
• 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.
• 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.

You may not qualify if:

• Patients who are concurrently receiving other therapies of the same class.
• Patients currently enrolled in another interventional clinical study.
• Females with confirmed pregnancy or during lactation.
• Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Lixiaoling: lead

Study Sites (1)

BeidahuangGGH

Harbin, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 4, 2026
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)