Actively Recruiting
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
Led by Sheng Zhang · Updated on 2025-12-30
90
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Age 18 years or older.
- Diagnosed with advanced tumor confirmed by histology and/or cytology and pathologically HER2-positive (HER2 21 1+ by immunohistochemistry).
- Cohort 1: Histologically confirmed extramammary Paget's disease with unresectable locally advanced or metastatic disease.
- Cohort 2: Histologically confirmed locally advanced or metastatic rare solid tumor refractory to standard treatment or with no standard treatment available.
- Cohort 3: Histologically confirmed locally advanced or metastatic urothelial carcinoma with progression after first-line treatment with PD-1/PD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin.
- ECOG Performance Status 0 to 2.
- At least one measurable lesion by RECIST v1.1 criteria.
- Adequate hematological function: ANC 21 1.5 x 109/L, Platelet count 21 70 x 109/L, Hemoglobin 21 80 g/L.
- Adequate hepatic function: total bilirubin 2c 1.5 x ULN, ALT and AST 2c 3 x ULN (2c 5 x ULN if liver metastases), serum albumin 21 28 g/L.
- Adequate renal function: serum creatinine 2c 1.5 x ULN or creatinine clearance 21 50 mL/min.
- Adequate coagulation function: INR and/or PT 2c 1.5 x ULN, aPTT 2c 1.5 x ULN.
- Estimated life expectancy of 3 months or more.
- Use medically approved contraception during treatment and for 120 days after study ends.
- Ability to comply with study visits and protocol requirements.
You will not qualify if you...
- Severe or uncontrolled diseases such as poorly controlled hypertension or diabetes.
- Grade 2 or higher myocardial ischemia, myocardial infarction, arrhythmia (QTcF 21 470 ms), or grade 2 or higher congestive heart failure.
- Active or uncontrolled severe infections including tuberculosis.
- History of active tuberculosis.
- Uncontrolled ascites, pericardial or pleural effusion requiring drainage.
- Active hepatitis with liver enzyme levels above inclusion limits or high HBV/HCV viral load.
- History of immunodeficiency including HIV.
- History of organ or stem cell transplantation.
- Presence of brain, leptomeningeal, or spinal metastases.
- Recent history (within 6 months) of severe gastrointestinal conditions or surgeries.
- Non-healing wounds or active ulcers.
- Unresolved toxicity from previous anti-cancer therapy worse than grade 1 (except alopecia).
- Major surgery or trauma within 28 days prior to treatment.
- History of severe hypersensitivity to monoclonal antibodies or study drug components.
- Participation in another clinical trial within 4 weeks prior to study.
- Live vaccine within 30 days before first dose or planned during study.
- History of severe allergy.
- Bleeding disorders or on thrombolytic therapy.
- History of drug abuse or psychiatric disorders affecting compliance.
- Neurological or psychiatric disorders such as dementia or epilepsy.
- Any condition that may seriously affect safety, study completion, or informed consent per investigator judgment.
- Any other reason making the subject unsuitable for the trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
S
Sheng Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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