Clinical trial · Observational
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
NCT07387874CI-TRIAL-00102345active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other Drugs | Drug | — | UNRESOLVED |
| Trastuzumab Rezetecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment arm
- description
- Trastuzumab Rezetecan: ± Other Drugs
- interventionNames
- Drug: Trastuzumab Rezetecan
- Drug: Other Drugs
Primary outcomes (1)
- measure
- Safety （Incidence of Grade ≥3 AEs）
- timeFrame
- From the first dose on Day 1 through the last dose, for up to 3 years
- description
- Safety （Incidence of Grade ≥3 AEs）
Secondary outcomes (5)
- measure
- ORR
- timeFrame
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.