CarcinomaPhase 21NCT05917158
A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma
A Phase 2 study testing RC48-ADC and JS001 in people with Carcinoma and Upper Tract Urothelial Carcinoma, run by Jinling Hospital, China at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Upper Tract Urothelial Carcinoma, UTUC
- What is being tested?
- RC48-ADC and JS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2022to Dec 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
- Written informed consent
- ≥18 years of age
- Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted.
- Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).
- Pathological tissue immunohistochemistry HER2 2~3+
- Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
- ECOG(Eastern Cooperative Oncology Group) performance is 0~2.
- Available for long-term follow-up
Who cannot join
- Evidence of distant metastases
- Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
- Un-resected macroscopic nodal disease
- Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
- Significant co-morbid conditions that would interfere with administration of protocol treatment
- Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
- Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
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
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, 210000
Le Qu, M.D., 15720625951, septsoul@hotmail.com
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.
Read the detailed description
This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.
- Conditions
- Carcinoma, Upper Tract Urothelial Carcinoma, UTUC
- Being tested
- RC48-ADC and JS001
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48-ADC and JS001Drug
Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg/kg in combination with JS001 (Toripalimab) 3mg/kg intravenously, followed by toripalimab (3 mg/kg) every 3 weeks for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC and JS001 | Experimental | Not described Receives: Drug: RC48-ADC and JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
5-year Disease-free survival
Measured: 5 years
Secondary outcomes (2)
Overall survival (OS)
5-year Overall Survival
Measured: Patients followed-up for 5 years
Metastasis free survival (MFS)
5-year Metastasis free survival
Measured: Patients are followed up for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start23 Nov 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917158
- Sponsor's protocol ID
- 2022DZKY-106-02
- Acronym
- 1
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of RC48-ADC Combined with JS001 in Postoperative Adjuvant Treatment of HER2-positive Upper Tract Urothelial Carcinoma (UTUC)
- ClinicalTrials.gov ID
- NCT05917158
- Acronym / sponsor ID
- 1 / 2022DZKY-106-02
- Conditions
- Carcinoma, Upper Tract Urothelial Carcinoma, UTUC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jun 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 study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.
Detailed description
This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC and JS001 | Experimental | Drug: RC48-ADC and JS001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- ≥18 years of age
- Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted.
- Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).
- Pathological tissue immunohistochemistry HER2 2~3+
Key exclusion criteria (7 listed)
- Evidence of distant metastases
- Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
- Un-resected macroscopic nodal disease
- Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
- Significant co-morbid conditions that would interfere with administration of protocol treatment
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 |
|---|---|---|
| RC48-ADC and JS001Patients in group will receive 6 x 3 week cycles of RC48-ADC (Disitamab Vedotin) 2mg/kg in combination with JS001 (Toripalimab) 3mg/kg intravenously, followed by toripalimab (3 mg/kg) every 3 weeks for up to 1 year. | Drug | RC48-ADC and JS001 |
Primary outcome
Disease-free survival (DFS)
Time frame: 5 years
5-year Disease-free survival
2 secondary outcomes
Overall survival (OS)
Time frame: Patients followed-up for 5 years
Metastasis free survival (MFS)
Time frame: Patients are followed up for 5 years
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 22 Jan 2025.
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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 RC48-ADC and JS001 in people with Carcinoma and Upper Tract Urothelial Carcinoma, run by Jinling Hospital, China 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 8 inclusion and 7 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 22 Jan 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 Le Qu, M.D. (15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 5 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 22 Jan 2025.