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NCT Number: NCT07387874

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Recurrent or Metastatic Solid Tumors Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BeidahuangGGH

Harbin, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Safety （Incidence of Grade ≥3 AEs）

    Time frame: From the first dose on Day 1 through the last dose, for up to 3 years

    Safety （Incidence of Grade ≥3 AEs）

Secondary outcomes

  1. ORR

    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

    Overall Response Rate

  2. PFS

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

    Progression Free Survival

  3. OS

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

    Overall Survival

  4. iORR

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

    Intracranial Objective Response Rate

  5. iPFS

    Time frame: 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

Other outcomes

  1. Correlation between HER2 Expression Levels and Safety and Efficacy

    Time frame: from the first drug administration up to 3 years

    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)

  2. Safety（ Incidence of AEs and SAEs）

    Time frame: From the first dose on Day 1 through the last dose, for up to 3 years

    Safety（ Incidence of AEs and SAEs）

Sponsors and collaborators

Lead sponsor

Lixiaoling

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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