Urachal CancerPhase 2NCT07309770
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
A Phase 2 study testing SHR-A1811 and Trastuzumab Rezetecan in people with Urachal Cancer and Advanced Solid Tumor Cancer, run by Sheng Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urachal Cancer, Advanced Solid Tumor Cancer, Antibody-drug Conjugates
- What is being tested?
- SHR-A1811 and Trastuzumab Rezetecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 11 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Platelet count (PLT) ≥ 70 × 10⁹/L
- Hemoglobin (HGB) ≥ 80 g/L
- Hepatic function:
- Serum total bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present)
- Serum albumin ≥ 28 g/L
- Renal function:
- Serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min (calculated using the standard Cockcroft-Gault formula)
- Coagulation function:
- International Normalized Ratio (INR) ≤ 1.5 and/or Prothrombin Time (PT) ≤ 1.5 × ULN
- Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
- Estimated life expectancy ≥ 3 months.
- Use of medically approved contraception during the treatment period and for at least 120 days after the end of the study; sperm donation or cryopreservation for fertilization purposes is not allowed during this period.
- Ability to comply with the study visit schedule and other protocol requirements.
Who cannot join
- 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.
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- Uncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.
- Active hepatitis (liver enzyme levels not meeting inclusion criteria; for Hepatitis B: HBV DNA ≥ 2000 IU/ml or ≥ 10⁴ copies/ml; for Hepatitis C: HCV RNA ≥ 2000 IU/ml or ≥ 10⁴ copies/ml; carriers with chronic hepatitis B virus [HBV DNA < 10⁴ IU/ml] may be enrolled if they receive concomitant antiviral therapy during the trial).
- History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known presence of brain metastases, leptomeningeal metastasis, spinal cord compression, or spinal metastasis.
- Within 6 months prior to the first dose: history of esophageal/gastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding; extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Presence of non-healing or poorly healed wounds, active ulcers.
- Toxicity from previous antineoplastic therapy that has not resolved to ≤ Grade 1 per NCI CTCAE v5.0 (except for alopecia).
- Major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or presence of long-term unhealed wounds or fractures.
- History of severe hypersensitivity reaction to monoclonal antibodies; known allergy to the active components or excipients of the study drug(s).
- Participation in another clinical trial within 4 weeks prior to the start of the study.
- Administration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.
- History of severe allergy.
- Bleeding tendency, coagulopathy, or undergoing thrombolytic therapy.
- History of drug abuse or inability to discontinue use, or history of psychiatric disorders.
- History of clear neurological or psychiatric disorders, such as dementia, epilepsy, or susceptibility to seizures.
- Any condition that, in the investigator's judgment, seriously endangers subject safety, affects subject completion of the study (e.g., severe diabetes, thyroid disease, psychosis), may compromise subject safety or the ability to provide informed consent (including abnormal laboratory findings), or involves psychological, familial, sociological, or geographical conditions that may preclude compliance with the study protocol and follow-up plan.
- Any other reason deemed by the investigator to make the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Sheng ZHANG, 021-64175590, wozhangsheng@hotmail.com
About this study
Official title: Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts
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.
- Being tested
- SHR-A1811, Trastuzumab Rezetecan
- Keywords
- Antibody-Drug Conjugates, Rare tumor, Extra-mammary Paget disease, Urachal cancer, Trastuzumab Rezetecan
- Medical subject headings
- Urachal cancer, Paget Disease, Extramammary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.
Trastuzumab RezetecanDrug
Patients who have failed standard therapy are treated with Trastuzumab Rezetecan
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Cohort1:Patients with histologically confirmed extramammary Paget's disease (EMPD) demonstrating HER2 expression (IHC ≥ 1+) and having unresectable locally advanced or metastatic disease.
Cohort2: Patients with histologically confirmed locally advanced or metastatic rare solid tumors (such as sarcoma, urachal carcinoma, etc.) demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression on or after standard therapy, or for whom no standard therapy is available, and with at least one measurable lesion.
Cohort3:Patients with histologically confirmed locally advanced or metastatic urothelial carcinoma demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression following first-line treatment with a PD-1/PD-L1 inhibitor in combination with Enfortumab Vedotin or Disitamab vedotin Receives: Drug: SHR-A1811; Drug: Trastuzumab Rezetecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria.
Objective Response Rate (ORR)
Measured: Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).
Secondary outcomes (3)
Time from treatment start to progression by RECIST V.1.1.
Progression-free survival(PFS)
Measured: From date of treatment until the date of first documented progression, assessed up to 100 months.
Time from treatment start to death of participants.
Overall Survival(OS)
Measured: From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months.
Type, incidence, severity, onset and end time of adverse events (AE) evaluated according by the version 5.0 of NCI-CTCAE.
Evaluation of safety
Measured: Began at 30 days (±7 days) after the last study treatment to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start18 Dec 2025 (estimated)
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urachal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-group study,three cohorts
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309770
- Sponsor's protocol ID
- A1811-US-03
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts
- ClinicalTrials.gov ID
- NCT07309770
- Acronym / sponsor ID
- A1811-US-03
- Keywords
- Antibody-Drug Conjugates, Rare tumor, Extra-mammary Paget disease, Urachal cancer, Trastuzumab Rezetecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sheng ZhangUniversity, hospital or other
- Study start
- 18 Dec 2025 (estimated)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Mar 2028 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-group study,three cohorts
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: SHR-A1811, Drug: Trastuzumab RezetecanCohort1:Patients with histologically confirmed extramammary Paget's disease (EMPD) demonstrating HER2 expression (IHC ≥ 1+) and having unresectable locally advanced or metastatic disease. Cohort2: Patients with histologically confirmed locally advanced or metastatic rare solid tumors (such as sarcoma, urachal carcinoma, etc.) demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression on or after standard therapy, or for whom no standard therapy is available, and with at least one measurable lesion. Cohort3:Patients with histologically confirmed locally advanced or metastatic urothelial carcinoma demonstrating HER2 expression (IHC ≥ 1+) , who have experienced disease progression following first-line treatment with a PD-1/PD-L1 inhibitor in combination with Enfortumab Vedotin or Disitamab vedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (24 listed)
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1811Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle. | Drug | Experimental group 1 |
| Trastuzumab RezetecanPatients who have failed standard therapy are treated with Trastuzumab Rezetecan | Drug | Experimental group 1 |
Primary outcome
The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria.
Time frame: Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).
Objective Response Rate (ORR)
3 secondary outcomes
Time from treatment start to progression by RECIST V.1.1.
Time frame: From date of treatment until the date of first documented progression, assessed up to 100 months.
Time from treatment start to death of participants.
Time frame: From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months.
Type, incidence, severity, onset and end time of adverse events (AE) evaluated according by the version 5.0 of NCI-CTCAE.
Time frame: Began at 30 days (±7 days) after the last study treatment to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-A1811 and Trastuzumab Rezetecan in people with Urachal Cancer and Advanced Solid Tumor Cancer, run by Sheng Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Zhang (+86 021-64175590, wozhangsheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria. (time frame: Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.