Muscle Invasive Bladder CancerPhase 2NCT05979740
RC48 Combined With Toripalimab and Radiotherapy for Bladder Sparing Treatment in MIBC
A Phase 2 study testing Disitamab Vedotin and Toripalimab in people with Muscle Invasive Bladder Cancer and HER2 Expression, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Cancer, HER2 Expression, Radiotherapy
- What is being tested?
- Disitamab Vedotin and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 13 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ECOG PS: 0～1；Subjects underwent TURBT surgery or partial cystectomy and imaging diagnosis, which was determined to be muscular infiltrating urothelial carcinoma of the bladder (urothelial carcinoma being the main pathological component: 50%) and planned to undergo radical total cystectomy + lymph node dissection + urine flow diversion; cT2-T4a N0 M0 (CT/MRI ± PET/CT)；Undergo TURBT or partial cystectomy；Tissue examination specimens with TURBT or partial cystectomy；Expected survival ≥3 months；Immunohistochemical staining of tissue after final TURBT or partial cystectomy showed IHC 2+ or 3+；The major organs are functioning normally, the following criteria are met:
- The blood routine examination criteria should meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment) :
- Absolute count of neutrophils (ANC) ≥1,000/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥ 8.0g /dL
- Liver function:
- Total bilirubin ≤1.5× prescribed ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5×ULN ii. Upper limit of normal values (ULN) ≤2.5 times of alanine Aminotransferase (ALT) and aspartate Aminotransferase (AST) Note: ≤1.5× ULN (This criterion only applies to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within therapeutic limits);
- Kidney function:
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- The Cockcroft-Gault formula was used to determine the creatinine clearance (CrCl) > 30 mL/min.
- Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study; Fertile women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the study drug is first administered.
- Exclusion criteria: Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, including adjuvant therapy stage；Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components；Those who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to study therapy, or had not recovered from previous toxicity (except for 2 degree hair loss and 1 degree neurotoxicity)；Pregnant or lactating woman；HIV positive；People with active hepatitis B or C；A history of definite active tuberculosis；Have active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., use of disease-regulating drugs, corticosteroids, or immunosuppressive drugs) that allow for relevant replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency)；Other serious, uncontrolled concomitant diseases that may affect protocol adherence or interfere with interpretation of results, These include active opportunistic or progressive (severe) infections, uncontrolled diabetes, cardiovascular disease (heart failure of Grade Ⅲ or Ⅳ as defined by the New York Heart Association scale, heart block of degree Ⅱ or higher, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.), or pulmonary disease (interstitial pneumonia, History of obstructive pulmonary disease and symptomatic bronchospasm)；Those who received the live vaccine within 4 weeks before treatment began；Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation；Major surgical procedures (excluding diagnostic surgery) within 4 weeks prior to the start of treatment；Those who have a history of psychotropic substance abuse and cannot abstain or have a history of mental disorders；A large amount of pleural fluid or ascites with clinical symptoms or symptomatic management；Have had other unhealed malignancies in the past 5 years, excluding those that are apparently cured or curable, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast; Remarks: Patients with localized low-risk prostate cancer (defined as stage ≤T2b, Gleason score ≤7, and PSA≤20ng/mL at the time of prostate cancer diagnosis (as measured) who had received radical therapy and had no biochemical recurrence of prostate specific antigen (PSA) were eligible to participate in this study)；Urothelial carcinoma associated with upper urinary tract (renal pelvis and ureteral urothelial carcinoma)；Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, according to the investigator, may increase the risks associated with study participation or may interfere with the interpretation of the study results
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ruiyun Zhang contact
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
haige chen, M.D, 86-21-68383575, kirbyhaige@aliyun.com
Haige Chen, M.D
About this study
Official title: RC48 Combined With PD-1 and Radiotherapy as Bladdersparing Therapy in Patients With Muscular Infiltrating Bladder Uroepithelial Carcinoma With Limited HER-2 Expression Following Maximum Electrical Resection or Partial Cystectomy
This is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP). Six patients were enrolled in this study. Each patient received RC48 injection [2.0 mg/kg, Q2W, iv] and Toripalimab injection [3mg/kg, Q2W, iv] for 1~2 cycles, and radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time. Adverse events were graded using the National Cancer Institute (NCI) Standard for the Assessment of Common Terminology for Adverse Events (CTCAE) Version 5.0 guidelines, and the occurrence of DLT in patients was observed. If the subject does not complete the safety assessment for the tolerance observation period for non-dose tolerance reasons, a new subject will be replaced.
Read the detailed description
This is a prospective, open, single-center clinical study of RC48 in combination with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP).
Subjects undergo maximum transurethral electrocystotomy (TURBT) or partial cystectomy, imaging diagnosis, and pre-treatment biological samples of blood, urine, and biopsy tissue. The researchers determined that localized invasive bladder cancer with high HER-2 expression could be treated with bladder conserving therapy with maximum TURBT. Patients will receive RC48 combined with PD-1 and radiotherapy after TURBT surgery. Subjects should receive RC48 combined with PD-1 every two weeks for 12 treatment cycles and radiotherapy (bladder irradiation field greater than 50Gy). After completion of the above treatment, tumor site pathology, imaging, and exfoliation cytology are obtained with diagnostic TURBT for tumor evaluation to determine complete remission, and the first tumor efficacy evaluation is performed after completion of radiotherapy (12 weeks after treatment) and every 12 weeks after completion of radiotherapy. Patients with radiotherapy intolerance (as assessed by the investigator) were discontinued directly.
Adverse events will be monitored during the study period and graded using the National Cancer Institute's (NCI) Standards for the Assessment of Adverse Events in General Terminology (CTCAE) Version 5.0 guidelines. The safety assessment was carried out after 28 days.
Subjects who discontinue medication for reasons other than disease progression will be followed for post-treatment disease status until subjects begin other antitumor therapy, develop disease progression, withdraw informed consent, die, or end of the study, whichever occurs first. All subjects will be followed up via outpatient cystoscopy (every 3 months within 1 year of withdrawal and every 6 months after 1 year) until subject's death, withdrawal of informed consent, or the end of the study, whichever occurs first.
Participation in this study will require participants to submit a TURBT tumor tissue specimen or a newly obtained tumor lesion biopsy from prior untreated radiation therapy for biomarker and efficacy correlation evaluation.
Blood and urine samples from patients will be collected during the treatment to explore potential biomarkers correlated to the treatment efficacy and patient response.
- Conditions
- Muscle Invasive Bladder Cancer, HER2 Expression, Radiotherapy, PD-1, Antibody-drug Conjugates
- Being tested
- Disitamab Vedotin and Toripalimab
- Keywords
- Muscle Invasive Bladder Cancer, HER2 expression, Radiotherapy, PD-1, ADC, Bladder Sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin and ToripalimabDrug
Also called RC48, JS001
Each patient received RC48 injection [2.0 mg/kg, Q2W, iv] and Toripalimab injection [3mg/kg, Q2W, iv] for 1~2 cycles, and Radiotherapy radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time.
| Study group | Role | What they receive |
|---|---|---|
| RC48+Toripalimab+Radiotherapy | Experimental | RC48: 2.0 mg/kg, Q2W, iv; Toripalimab: 3mg/kg, Q2W, iv; Radiotherapy: total dose was greater than 50Gy (about 30 times). Receives: Drug: Disitamab Vedotin and Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events will be defined according to NCI CTCAE, Version 5.0
Measured: Up to 28 days
Secondary outcomes (7)
Percent of Patients With Complete Response (CR)
CR is defined by negative cystoscopy, urine cytology, and bladder biopsies.
Measured: Up to 3 months
Percent of Patients With Complete Response (CR)
CR is defined by negative cystoscopy, urine cytology, and bladder biopsies.
Measured: Up to 12 months
Percent of Patients With Complete Response (CR)
CR is defined by negative cystoscopy, urine cytology, and bladder biopsies.
Measured: Up to 24 months
1-yr and 2-yr Bladder-intact Event-free Survival (BI-EFS)
Defined by time from enrollment to the occurrence of one of the following events: disease progression, switch to other therapy, intolerant adverse events, or death
Measured: Up to 24 months
Recurrence Free Survival (RFS)
Defined by time from day of first treatment to recurrent NMIBC based on cystoscopy, cytology and/or biopsy.
Measured: Up to 24 months
Overall Survival (OS)
Defined by time from day of first treatment to death
Measured: Up to 24 months
Cancer-Specific Survival
Defined by time from day of first treatment to metastatic bladder cancer
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023
- Primary completion13 Dec 2023 (estimated)
- Study completion13 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haige Chen, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979740
- Sponsor's protocol ID
- LY2023-002-A
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Jin D, Zang J, Qian L, Zhang T, Wu Y, Ding Y, Xie F, Tang H, Xia J, Cao D, Zhang R, Zhuang G, Chen H. Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study. Neoplasia. 2025 Oct;68:101216. doi: 10.1016/j.neo.2025.101216. Epub 2025 Aug 6.
PubMed 40774226
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RC48 Combined With PD-1 and Radiotherapy as Bladdersparing Therapy in Patients With Muscular Infiltrating Bladder Uroepithelial Carcinoma With Limited HER-2 Expression Following Maximum Electrical Resection or Partial Cystectomy
- ClinicalTrials.gov ID
- NCT05979740
- Acronym / sponsor ID
- LY2023-002-A
- Conditions
- Muscle Invasive Bladder Cancer, HER2 Expression, Radiotherapy, PD-1, Antibody-drug Conjugates
- Keywords
- Muscle Invasive Bladder Cancer, HER2 expression, Radiotherapy, PD-1, ADC, Bladder Sparing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 13 Dec 2023 (estimated)
- Study completion
- 13 Feb 2024 (estimated)
- First posted
- 7 Aug 2023 (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 is a prospective, open, single-center clinical study of RC48 combined with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP). Six patients were enrolled in this study. Each patient received RC48 injection [2.0 mg/kg, Q2W, iv] and Toripalimab injection [3mg/kg, Q2W, iv] for 1~2 cycles, and radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time. Adverse events were graded using the National Cancer Institute (NCI) Standard for the Assessment of Common Terminology for Adverse Events (CTCAE) Version 5.0 guidelines, and the occurrence of DLT in patients was observed. If the subject does not complete the safety assessment for the tolerance observation period for non-dose tolerance reasons, a new subject will be replaced.
Detailed description
This is a prospective, open, single-center clinical study of RC48 in combination with PD-1 and radiotherapy as bladder-preserving therapy in patients with muscular invasive bladder uroepithelial carcinoma with high HER-2 expression (IHC 2+ or 3+). The study was conducted in accordance with the Good Practice for Clinical Trials of Pharmaceutical Products (GCP).
Subjects undergo maximum transurethral electrocystotomy (TURBT) or partial cystectomy, imaging diagnosis, and pre-treatment biological samples of blood, urine, and biopsy tissue. The researchers determined that localized invasive bladder cancer with high HER-2 expression could be treated with bladder conserving therapy with maximum TURBT. Patients will receive RC48 combined with PD-1 and radiotherapy after TURBT surgery. Subjects should receive RC48 combined with PD-1 every two weeks for 12 treatment cycles and radiotherapy (bladder irradiation field greater than 50Gy). After completion of the above treatment, tumor site pathology, imaging, and exfoliation cytology are obtained with diagnostic TURBT for tumor evaluation to determine complete remission, and the first tumor efficacy evaluation is performed after completion of radiotherapy (12 weeks after treatment) and every 12 weeks after completion of radiotherapy. Patients with radiotherapy intolerance (as assessed by the investigator) were discontinued directly.
Adverse events will be monitored during the study period and graded using the National Cancer Institute's (NCI) Standards for the Assessment of Adverse Events in General Terminology (CTCAE) Version 5.0 guidelines. The safety assessment was carried out after 28 days.
Subjects who discontinue medication for reasons other than disease progression will be followed for post-treatment disease status until subjects begin other antitumor therapy, develop disease progression, withdraw informed consent, die, or end of the study, whichever occurs first. All subjects will be followed up via outpatient cystoscopy (every 3 months within 1 year of withdrawal and every 6 months after 1 year) until subject's death, withdrawal of informed consent, or the end of the study, whichever occurs first.
Participation in this study will require participants to submit a TURBT tumor tissue specimen or a newly obtained tumor lesion biopsy from prior untreated radiation therapy for biomarker and efficacy correlation evaluation.
Blood and urine samples from patients will be collected during the treatment to explore potential biomarkers correlated to the treatment efficacy and patient response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48+Toripalimab+Radiotherapy | Experimental | Drug: Disitamab Vedotin and ToripalimabRC48: 2.0 mg/kg, Q2W, iv; Toripalimab: 3mg/kg, Q2W, iv; Radiotherapy: total dose was greater than 50Gy (about 30 times). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ECOG PS: 0～1；Subjects underwent TURBT surgery or partial cystectomy and imaging diagnosis, which was determined to be muscular infiltrating urothelial carcinoma of the bladder (urothelial carcinoma being the main pathological component: 50%) and planned to undergo radical total cystectomy + lymph node dissection + urine flow diversion; cT2-T4a N0 M0 (CT/MRI ± PET/CT)；Undergo TURBT or partial cystectomy；Tissue examination specimens with TURBT or partial cystectomy；Expected survival ≥3 months；Immunohistochemical staining of tissue after final TURBT or partial cystectomy showed IHC 2+ or 3+；The major organs are functioning normally, the following criteria are met:
- The blood routine examination criteria should meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment) :
- Liver function:
- Kidney function:
- The Cockcroft-Gault formula was used to determine the creatinine clearance (CrCl) > 30 mL/min.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Disitamab Vedotin and ToripalimabAlso: RC48, JS001Each patient received RC48 injection [2.0 mg/kg, Q2W, iv] and Toripalimab injection [3mg/kg, Q2W, iv] for 1~2 cycles, and Radiotherapy radiotherapy at the second or third cycle. The total dose of bladder irradiation field was greater than 50Gy (about 30 times), and the safety monitoring of the subjects was conducted within 28 days after receiving the study drug treatment for the first time. | Drug | RC48+Toripalimab+Radiotherapy |
Primary outcome
Safety
Time frame: Up to 28 days
Adverse events will be defined according to NCI CTCAE, Version 5.0
7 secondary outcomes
Percent of Patients With Complete Response (CR)
Time frame: Up to 3 months
Percent of Patients With Complete Response (CR)
Time frame: Up to 12 months
Percent of Patients With Complete Response (CR)
Time frame: Up to 24 months
1-yr and 2-yr Bladder-intact Event-free Survival (BI-EFS)
Time frame: Up to 24 months
Recurrence Free Survival (RFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Cancer-Specific Survival
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 40774226Zhang L, Jin D, Zang J, Qian L, Zhang T, Wu Y, Ding Y, Xie F, Tang H, Xia J, Cao D, Zhang R, Zhuang G, Chen H. Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study. Neoplasia. 2025 Oct;68:101216. doi: 10.1016/j.neo.2025.101216. Epub 2025 Aug 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ruiyun Zhang contact
Haige Chen principal investigator
RenJi Hospital
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 Disitamab Vedotin and Toripalimab in people with Muscle Invasive Bladder Cancer and HER2 Expression, run by RenJi Hospital 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haige Chen (02168383575, kirbyhaige@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 28 days). 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 NCT05979740, which also lists 1 linked publication.
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 31 Aug 2023.