AzTrials
AzTrials

Urothelial CarcinomaPhase 2TRAIN-UC-01NCT07241793

Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

A Phase 2 study testing Adebrelimab and Trastuzumab Rezetecan in people with Urothelial Carcinoma and Advanced Urothelial Carcinoma, run by Sun Yat-sen University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adebrelimab and Trastuzumab Rezetecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
6 sitesChina
Study dates
20 Nov 2025to 1 Jul 2031
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

  • Patients included in this study must meet all of the following criteria:
  • Age ≥ 18 years;
  • Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la/mUC), including bladder, ureter, renal pelvis, and urethra. HER2 expression is defined as immunohistochemical (IHC) staining results of 1+ to 3+, and must be confirmed by the pathology department of Sun Yat-sen University Cancer Center according to ASCO/CAP guidelines.
  • Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed/progressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2: Patients who have not received prior systemic therapy or relapsed/progressed more than 12 months after neoadjuvant/adjuvant therapy, or those who could not tolerate treatment due to AEs. Cohort 3: Patients who have previously received platinum-based chemotherapy (including cisplatin, carboplatin, etc.), immunotherapy (including PD-1, PD-L1 inhibitors), and Disitamab Vedotin ;
  • At least one measurable target lesion according to RECIST 1.1 criteria;
  • ECOG performance status ≤ 2;
Show all 11Show fewer
  • Adequate bone marrow, renal (calculated creatinine clearance > 30 mL/min using the CG formula), hepatic, and coagulation function;
  • Expected survival ≥ 3 months;
  • The patient understands the study procedures and has provided written informed consent to participate in the study;
  • Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required.
  • Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study treatment.

Who cannot join

  • Locally advanced patients who are candidates for curative local treatment;
  • Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological/psychiatric diseases;
  • Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at least 1 month and have discontinued corticosteroids for > 2 weeks;
  • Known severe allergic reactions to the study drug's active ingredients and/or excipients, or allergy to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab);
  • Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from adverse events;
  • Participated in any investigational drug treatment within 4 weeks before the study started;
Show all 20Show fewer
  • Known or suspected interstitial lung disease, or moderate to severe pulmonary diseases that might interfere with the evaluation of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia, bronchitis obliterans, pulmonary embolism, severe asthma, COPD, restrictive pulmonary diseases, or any autoimmune, connective tissue or inflammatory lung diseases, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or a history of total lung resection;
  • Known hereditary or acquired bleeding disorders (e.g., hemophilia, coagulopathy);
  • Received spinal cord radiation or has not recovered from radiation-related adverse events within 4 weeks before study start;
  • Diagnosed with immunodeficiency or received systemic corticosteroid treatment or any other immunosuppressive therapy within 7 days before the first study drug administration. Physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) are allowed;
  • Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., requiring disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapies (e.g., thyroid hormones, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. A history of non-infectious pneumonia requiring corticosteroid treatment or current interstitial lung disease within 1 year before the first dose is excluded;
  • History of organ or hematopoietic stem cell transplantation;
  • Known HIV infection (HIV 1/2 positive);
  • Untreated active hepatitis B (HBV). Note: Hepatitis B carriers with an HBV viral load < 1000 copies/mL (200 IU/mL) before the first dose are eligible, but should receive antiviral therapy during chemotherapy to prevent reactivation.
  • For anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load subjects, preventive antiviral therapy is not required, but close monitoring is necessary.
  • Active hepatitis C (HCV) infection (HCV antibody positive and HCV RNA level above detection threshold;
  • Received live vaccines within 30 days before the first dose of the study drug. Note: Inactivated flu vaccines are allowed within 30 days before the first dose, but live attenuated flu vaccines are not permitted.
  • History of other malignancies within the past 3 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or low-risk prostate cancer (T2N0M0, Gleason score <7, or undetectable PSA);
  • Any condition or disease history that may interfere with the study results or hinder the participant's full participation, including abnormal laboratory values, or situations deemed inappropriate by the investigator;
  • Breastfeeding women.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yanxia Shi, Doctor contact

86-020-87343486

shiyx@sysucc.org.cn

Haifeng Li, Doctor contact

86-020-87343486

lihf@sysucc.org.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

    Tao Qin, Doctor, 86-020-81332199, shiyx@sysucc.org.cn

    Not yet recruiting

  • Sun yat-sen university cancer center

    Guangzhou, Guangdong, 510000

    Yanxia Shi, Doctor, 86-020-87343486, shiyx@sysucc.org.cn

    Haifeng Li, Doctor, lihf@sysucc.org.cn

    Recruiting

  • The fifth Affiliated Hospital of Guangzhou Medcial University

    Guangzhou, Guangdong, 510000

    Guifang Yu, Doctor, 86-020-85959142, shiyx@sysucc.org.cn

    Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650033

    Xuefen Lei, Doctor, 86-0871-65351281, shiyx@sysucc.org.cn

    Not yet recruiting

  • Jiangxi Cancer Center

    Nanchang, Jiangxi, 330000

    Zhiming Qiu, Doctor, 02087343801, shiyx@sysucc.org.cn

    Recruiting

  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Bo Liu, Doctor, 86-027-83663200, shiyx@sysucc.org.cn

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)

This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC).

Read the detailed description

This multicenter Phase II study aims to investigate the clinical efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC). The study includes three cohorts based on their prior treatment history and relapse/progression status: Cohort 1 includes patients who have received at least one prior systemic therapy and relapsed/progressed within 12 months; Cohort 2 includes patients who have not received prior systemic therapy or relapsed/progressed more than 12 months after neo-adjuvant/adjuvant treatment; Cohort 3 includes patients who have previously received platinum-based chemotherapy, immunotherapy, or Disitamab Vedotin. The study will provide important data on the combination therapy of Trastuzumab Rezetecan and Adebrelimab, potentially offering a new treatment option for patients with HER2-expressing advanced UC .

Being tested
Adebrelimab, Trastuzumab Rezetecan
Keywords
Urothelial carcinoma, Antibody-Drug Conjugate, immune checkpoint inhibitor
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    Adebrelimab (1200 mg) every 3 weeks (Q3W).

  • Trastuzumab RezetecanDrug

    Trastuzumab Rezetecan (4.8 mg/kg) every 3 weeks (Q3W).

Study groups in NCT07241793
Study groupRoleWhat they receive
Cohort 1:Adebrelimab and Trastuzumab Rezetecan in Patients with Prior Systemic TherapyExperimentalPatients with locally advanced or metastatic UC (la/mUC) who have previously received at least one systemic treatment or experienced relapse/progression within 12 months following the last treatment, or those unable to tolerate treatment due to adverse events.
Receives: Drug: Adebrelimab; Drug: Trastuzumab Rezetecan
Cohort 2: Adebrelimab and Trastuzumab Rezetecan in Treatment-Naive or Relapsed PatientsExperimentalPatients locally advanced or metastatic UC (la/mUC) who have not received prior systemic therapy or who have relapsed/progressed more than 12 months after receiving neoadjuvant/adjuvant therapy, or those who cannot tolerate treatment due to adverse events.
Receives: Drug: Adebrelimab; Drug: Trastuzumab Rezetecan
Cohort 3: Trastuzumab Rezetecan in Patients with Prior Platinum and Immune TherapyExperimentalPatients locally advanced or metastatic UC (la/mUC) who have previously been treated with platinum-based chemotherapy (including cisplatin, carboplatin), immune checkpoint inhibitors (such as PD-1, PD-L1 inhibitors), and Disitamab Vedotin .
Receives: Drug: Trastuzumab Rezetecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as determined by RECIST v1.1 criteria, based on radiologic assessment. Responses will be confirmed by at least one subsequent imaging assessment.

    Measured: Within approximately 36 months

Secondary outcomes (8)

  1. Progression-free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression, as determined by RECIST v1.1, or death from any cause, whichever occurs first. Disease progression will be assessed by independent radiologic review. Patients without documented progression or death at the time of analysis will be censored at their last tumor assessment date.

    Measured: Within approximately 36 months

  2. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the first dose of study treatment to death from any cause. Participants still alive at the time of analysis will be censored at the date of their last follow-up.

    Measured: Within approximately 36 months

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) for at least 6 weeks after treatment initiation, based on RECIST v1.1 criteria.

    Measured: Within approximately 36 months

  4. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from the first dose of study treatment to the first occurrence of a confirmed objective response (CR or PR) as determined by RECIST v1.1 criteria.

    Measured: Within approximately 36 months

  5. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the time from the first documented objective response (CR or PR) to disease progression or death, whichever occurs first, based on RECIST v1.1 criteria.

    Measured: Within approximately 36 months

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    The number of participants who experience treatment-related adverse events (AEs) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. AEs will be graded on a scale from Grade 1 (mild) to Grade 5 (death related to AE). The severity, frequency, and type of AEs will be recorded and summarized. The results will be presented as the total number and percentage of participants experiencing any treatment-related AE, as well as a breakdown by AE grade and type. Treatment-related AEs will be determined by the investigator's clinical judgment based on available data.

    Measured: Within approximately 36 months

  7. Health-Related Quality of Life (HRQoL) as Assessed by the EORTC QLQ-C30 Questionnaires

    The EORTC QLQ-C30 will assess global health status, physical and emotional functioning, and cancer-related symptoms such as fatigue, pain, nausea, and appetite loss. The tool also evaluates functional scales across physical, role, emotional, cognitive, and social domains. The QLQ-C30 is a widely validated tool for cancer patients' HRQoL assessment.

    Scores for each domain range from 0 to 100. Each functional domain score (physical, role, emotional, cognitive, and social) is calculated by averaging the responses for the items within that domain. Symptom domain scores (e.g., fatigue, pain) are also calculated by averaging their respective items. A higher score for symptom domains indicates worse quality of life, while a higher score for functional domains indicates better quality of life.

    Measured: Within approximately 36 months

  8. Health-Related Quality of Life (HRQoL) as Assessed by the EQ-5D

    Health-related quality of life will be assessed using the EQ-5D, which is a standardized tool for measuring general health status. The EQ-5D assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level scale: 1. No problems ；2. Some problems；3. Extreme problems.

    The EQ-5D index score is calculated based on the responses for each dimension. A higher score indicates better health status. Additionally, the Visual Analog Scale (VAS) will be used, where participants rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: Within approximately 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start20 Nov 2025
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2031 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Study Design: Cohort 1: Patients with locally advanced or metastatic UC (la/mUC) who have previously received at least one systemic treatment or experienced relapse/progression within 12 months following the last treatment, or those who are unable to tolerate treatment due to adverse events. Cohort 2: Patients with locally advanced or metastatic UC (la/mUC) who have not received prior systemic therapy or who have relapsed/progressed more than 12 months after receiving neoadjuvant/adjuvant therapy, or those who cannot tolerate treatment due to adverse events. Cohort 3: Patients with locally advanced or metastatic UC (la/mUC) who have previously been treated with platinum-based chemotherapy (including cisplatin, carboplatin), immune checkpoint inhibitors (such as PD-1, PD-L1 inhibitors), and Disitamab Vedotin .
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241793
Sponsor's protocol ID
2025-FXY-281
Acronym
TRAIN-UC-01
Status last verified
Apr 2026
First submitted
24 Sep 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to ethical and privacy concerns.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab and Trastuzumab Rezetecan in people with Urothelial Carcinoma and Advanced Urothelial Carcinoma, run by Sun Yat-sen University at 6 sites 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 11 inclusion and 20 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 Yanxia Shi, Doctor (86-020-87343486, shiyx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Within approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07241793.

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 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in