Intermediate and High-risk Non-muscle Invasive Bladder CancerPhase 1NCT06108492
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase 1 study testing SHR-2005 in people with Intermediate and High-risk Non-muscle Invasive Bladder Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate and High-risk Non-muscle Invasive Bladder Cancer
- What is being tested?
- SHR-2005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to 30 Sep 2027
- Phase
- Phase 1
- 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
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- ≥18 years of age, either sex;
- Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
- ECOG performance status of 0-1;
- Life expectancy ≥ 2 years;
- Adequate bone marrow and organ function.
Who cannot join
- Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 2 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
- Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;
- Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
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 Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jianming Guo, Doctor, +86-13681971306, Guo.jianming@zs-hospital.sh.cn
About this study
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
- Being tested
- SHR-2005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2005Drug
In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period.
In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
| Study group | Role | What they receive |
|---|---|---|
| SHR-2005 | Experimental | Only one arm with SHR-2005 Receives: Drug: SHR-2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: From Day 1 to Day 21
Maximum tolerated dose (MTD)
Measured: From Day 1 to Day 21
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
Measured: From Day 1 to 90 days after last dose
RP2D（Recommended Phase 2 dose）
Measured: From Day 1 to 90 days after last dose
Secondary outcomes (8)
PK parameter: Tmax of SHR-2005
Time to maximum concentration of SHR-2005
Measured: approximately 24 months
PK parameter: Cmax of SHR-2005
Maximum concentration of SHR-2005
Measured: approximately 24 months
PK parameter: AUC0-∞ of SHR-2005
area under the concentration-time curve from time 0 to infinity of SHR-2005
Measured: approximately 24 months
Immunogenicity of SHR-2005
Anti- SHR-2005 antibody (ADA)
Measured: approximately 24 months
Duration of response (DoR)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Disease control rate (DCR)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Progression-free survival (PFS)
Evaluated using RECIST 1.1
Measured: approximately within 36 months
Amount_recovered and Percent_recovered
The Amount _ recovered and Percent _ recovered of SHR-2005 in urine after intravesical instillation.
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start28 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate and High-risk Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108492
- Sponsor's protocol ID
- SHR-2005-I-101
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2023
- Last updated
- 3 Dec 2024
- Results posted
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
- ClinicalTrials.gov ID
- NCT06108492
- Acronym / sponsor ID
- SHR-2005-I-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 31 Oct 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 is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
| Arm | Type | Receives |
|---|---|---|
| SHR-2005 | Experimental | Drug: SHR-2005Only one arm with SHR-2005 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- ≥18 years of age, either sex;
- Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;
- ECOG performance status of 0-1;
- Life expectancy ≥ 2 years;
Key exclusion criteria (7 listed)
- Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 2 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;
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-2005In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy. | Drug | SHR-2005 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: From Day 1 to Day 21
Maximum tolerated dose (MTD)
Time frame: From Day 1 to Day 21
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
Time frame: From Day 1 to 90 days after last dose
RP2D（Recommended Phase 2 dose）
Time frame: From Day 1 to 90 days after last dose
8 secondary outcomes
PK parameter: Tmax of SHR-2005
Time frame: approximately 24 months
PK parameter: Cmax of SHR-2005
Time frame: approximately 24 months
PK parameter: AUC0-∞ of SHR-2005
Time frame: approximately 24 months
Immunogenicity of SHR-2005
Time frame: approximately 24 months
Duration of response (DoR)
Time frame: approximately within 36 months
Disease control rate (DCR)
Time frame: approximately within 36 months
Progression-free survival (PFS)
Time frame: approximately within 36 months
Amount_recovered and Percent_recovered
Time frame: approximately 24 months
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 3 Dec 2024.
- 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 1 study testing SHR-2005 in people with Intermediate and High-risk Non-muscle Invasive Bladder Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. 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 6 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 3 Dec 2024. 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 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.
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 Shouwei Zhao (0518-82342973, shouwei.zhao@hengrui.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 toxicities (DLTs) (time frame: From Day 1 to Day 21). 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?
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 3 Dec 2024.