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RECRUITINGPHASE2

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts

NCT07309770•Sheng Zhang

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Summary

This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntarily sign a written informed consent form.
•Age ≥ 18 years.
•Diagnosed with the corresponding advanced tumor confirmed by histology and/or cytology, combined with imaging or ultrasound assessment, and pathologically confirmed as HER2-positive (i.e., HER2 ≥ 1+ by immunohistochemistry \[IHC\]).
•Cohort 1 only: Histologically confirmed extramammary Paget's disease (EMPD) with unresectable locally advanced or metastatic disease.
•Cohort 2 only: Histologically confirmed locally advanced or metastatic rare solid tumor (e.g., sarcoma, urachal cancer) refractory to standard treatment or for whom no standard treatment is available.
•Cohort 3 only: Histologically confirmed locally advanced or metastatic urothelial carcinoma with disease progression following first-line treatment with a PD-1/PD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin.
•ECOG Performance Status: 0 to 2.
•At least one measurable lesion (according to RECIST v1.1 criteria: non-nodal lesions with longest diameter ≥10 mm on CT scan, nodal lesions with short axis ≥15 mm on CT scan).
•Hematological function:
•Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
+30 more criteria

Exclusion Criteria

•Subjects who meet any of the following criteria will be excluded from participation in this study:
•Presence of any severe and/or uncontrolled disease, including:
•Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L).
•≥ Grade 2 myocardial ischemia, myocardial infarction, arrhythmia (QTcF ≥ 470 ms), or ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification).
•Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection.
•History of active tuberculosis.
•Uncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 18, 2025

Primary Completion Date

September 11, 2027

Completion Date

March 11, 2028

Last Updated

December 30, 2025

Enrollment

ESTIMATED participants

Conditions

Urachal CancerAdvanced Solid Tumor CancerAntibody-drug Conjugates

Interventions

SHR-A1811

DRUG

Trastuzumab Rezetecan

DRUG

Contacts

Sheng Zhang

CONTACT

+86 021-64175590 wozhangsheng@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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