High-risk Non-muscle Invasive Bladder CancerPhase 1/2NCT06378242
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
A Phase 1/2 study testing Disitamab Vedotin for injection in people with High-risk Non-muscle Invasive Bladder Cancer, run by RemeGen Co., Ltd. at 6 sites in China.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High-risk Non-muscle Invasive Bladder Cancer
- What is being tested?
- Disitamab Vedotin for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesChina
- Study dates
- 14 Jun 2024to 31 Dec 2029
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in the study and signed the informed consent form.
- Male or female, age 18-75 years (including both).
- Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
- Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:
- a.Carcinoma in situ (CIS) b. T1 stage c. diameter>3cm d.Multiple tumors, or recurrent tumors.
- Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
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- The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
- Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate heart, bone marrow, liver, kidney and coagulation function
Who cannot join
- 1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
- 2. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
- 3. Any other antitumor therapy received within 4 weeks before study administration, .
- 4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.
- 5, Known allergic to DV and its components or to any excipients.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan
Shusuan Jiang, M.D
- Not yet recruiting
West China Hospital
Chengdu, Sichuan
Peng Zhang, M.D
- Recruiting
Sun Yat-sen Memorial Hospital,SunYat-sen University
Guangzhou, Guangdong
Tianxin Lin, Ph.D
- Not yet recruiting
The first affiliated hospital with nanjing medical universtity
Nanjing, Jiangsu
qiang Lv, M.D
- Not yet recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality
Hailong Hu, M.D
- Not yet recruiting
Tongji Hospital
Wuhan, Hubei
Shaogang Wang, M.D
About this study
Official title: An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Read the detailed description
This is a single-arm, multicenter phase I/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.
- Being tested
- Disitamab Vedotin for injection
- Keywords
- HER2-expression, High-risk non-muscle invasive bladder cancer, intravesical instiliations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin for injectionDrug
Also called RC48
Intravesical instiliations into the bladder
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Intravesical instiliations :Dose escalation cohort | Experimental | Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week. Receives: Drug: Disitamab Vedotin for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity(DLT) (Phase I)
Measured: Approximately 21 days
Incidence of Adverse event (Phase I)
According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Measured: Approximately 1 years
Recommended Phase II Dose(RP2D)
Assessed based on the Incidence of DLT
Measured: Approximately 21 days
Maximum Tolerated Dosage(MTD)
Assessed based on the Incidence of DLT
Measured: Approximately 21 days
Secondary outcomes (5)
Disease-free survival (DFS) rates
Disease-free survival (DFS) rates was defined as the time from the date of first study treatment to the time of the subject's first high-grade Ta, T1 of any grade, CIS lasting greater than or equal to 6 months, new carcinoma in situ (CIS), cystectomy, disease progression, or death from any cause
Measured: Up to approximately 2 years
Duration of response (DOR)
Defined as the time from the start of the first assessment of CR to the first assessment of high grade Ta, any grade of T1, new CIS, disease progression, cystectomy, or death from any cause
Measured: Up to approximately 2 years
Disitamab Vedotin anti-drug antibody (ADA)
The number and proportion of anti-drug antibody (ADA)-positive subjects were analyzed according to dose group and time point.
Measured: Up to approximately 2 years
PK of enfortumab vedotin: Maximum concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Measured: Approximately 1 years
PK of enfortumab vedotin: Trough concentration (Ctrough)
Ctrough will be recorded from the PK blood samples collected.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start14 Jun 2024
- Primary completion15 Mar 2029 (estimated)
- Study completion31 Dec 2029 (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 High-risk Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378242
- Sponsor's protocol ID
- RC48-C029
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Huang M, Chen Z, Zhang C, Pan B, Liu C, Xu W, Fang J, Huang J, Lin T. Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm, Dose-Escalation Phase I Trial Study. MedComm (2020). 2025 Jul 13;6(7):e70288. doi: 10.1002/mco2.70288. eCollection 2025 Jul.
PubMed 40661136
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Single-arm, Multicenter Phase I/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
- ClinicalTrials.gov ID
- NCT06378242
- Acronym / sponsor ID
- RC48-C029
- Keywords
- HER2-expression, High-risk non-muscle invasive bladder cancer, intravesical instiliations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Apr 2024 (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.
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
Detailed description
This is a single-arm, multicenter phase I/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Intravesical instiliations :Dose escalation cohort | Experimental | Drug: Disitamab Vedotin for injectionParticipants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary consent to participate in the study and signed the informed consent form.
- Male or female, age 18-75 years (including both).
- Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.
- a.Carcinoma in situ (CIS) b. T1 stage c. diameter>3cm d.Multiple tumors, or recurrent tumors.
- Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
Key exclusion criteria (5 listed)
- 1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
- 2. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
- 3. Any other antitumor therapy received within 4 weeks before study administration, .
- 4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.
- 5, Known allergic to DV and its components or to any excipients.
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 for injectionAlso: RC48Intravesical instiliations into the bladder | Drug | Disitamab Vedotin Intravesical instiliations :Dose escalation cohort |
Primary outcome
Incidence of dose-limiting toxicity(DLT) (Phase I)
Time frame: Approximately 21 days
Incidence of Adverse event (Phase I)
Time frame: Approximately 1 years
According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
Recommended Phase II Dose(RP2D)
Time frame: Approximately 21 days
Assessed based on the Incidence of DLT
Maximum Tolerated Dosage(MTD)
Time frame: Approximately 21 days
Assessed based on the Incidence of DLT
5 secondary outcomes
Disease-free survival (DFS) rates
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Disitamab Vedotin anti-drug antibody (ADA)
Time frame: Up to approximately 2 years
PK of enfortumab vedotin: Maximum concentration (Cmax)
Time frame: Approximately 1 years
PK of enfortumab vedotin: Trough concentration (Ctrough)
Time frame: Approximately 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 11 Jul 2024.
- Derived from this study: PubMed 40661136Chen X, Huang M, Chen Z, Zhang C, Pan B, Liu C, Xu W, Fang J, Huang J, Lin T. Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm, Dose-Escalation Phase I Trial Study. MedComm (2020). 2025 Jul 13;6(7):e70288. doi: 10.1002/mco2.70288. eCollection 2025 Jul.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Disitamab Vedotin for injection in people with High-risk Non-muscle Invasive Bladder Cancer, run by RemeGen Co., Ltd. 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 10 inclusion and 5 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 11 Jul 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hong Luo (+8610-58075763, hong.luo@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity(DLT) (Phase I) (time frame: Approximately 21 days). The study lists 4 primary outcomes in all. 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 NCT06378242, 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 11 Jul 2024.