High-risk NMIBCPhase 1/2NCT05410730
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
A Phase 1/2 study testing SHR-1501 in people with High-risk NMIBC, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk NMIBC
- What is being tested?
- SHR-1501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2022to May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
- Age ≥ 18 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Expected survival time ≥ 2 years;
- High-risk NMIBC diagnosed by previous pathological biopsy
- Cystoscopy within 6 weeks before the first administration shows that the lesion has been completely removed, or the residual lesion is only carcinoma in situ; for T1 stage lesions, postoperative pathological results must show the presence of bladder muscle tissue;
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- ineligible or unwilling to undergo radical cystectomy;
- The level of organ function is good.
- use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and the female subject and the female partner of the male subject should use highly effective contraceptive methods; the female subject of childbearing age without surgical sterilization must be negative for serum HCG within 7 days before the first administration and must be non-lactating.
Who cannot join
- Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Those who have previously received the following treatments and have not experienced disease progression before enrolment t as assessed by the investigator:
- Intravesical instillation of cytotoxic chemotherapy or other drugs;
- Immune checkpoint inhibitor;
- Other investigational products for the treatment of NMIBC.
- Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
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- Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
- Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
- Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
- Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
- Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment;
- Using of immunosuppressive drugs within 2 weeks prior to the first administration, excluding nasal and inhaled corticosteroids, low physiological doses of systemic steroids, and prophylactic anti allergic steroids;
- Active or history of interstitial lung disease;
- History of clinically significant cardiovascular disease
- A history of immunodeficiency, including HIV seropositive, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or those who are using immunosuppressants;
- With a history of active autoimmune disease；
- Patient with active hepatitis B (HBeAg positive and HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA higher than the detection limit of the analytical method);
- Known allergic or intolerance to study drug, BCG (Phase Ib and Phase II subjects only) or excipients;
- The presence of other serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study, or interfere with the results of the study; and any other conditions that the investigator deems inappropriate to participate in this study.
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
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhisong He
About this study
Official title: Phase I/II Clinical Study of Dose Escalation and Dose Expansion of SHR-1501 Alone or in Combination With Bacille de Calmette Guerin （BCG） or SHR-1316 in the Treatment of Non-muscle Invasive Bladder Cancer（NMIBC）
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
- Conditions
- High-risk NMIBC
- Being tested
- SHR-1501
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1501Drug
SHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1501 | Experimental | * Phase I：Phase Ia and Ib： Phase Ia include SHR-1501 dose escalation and expansion; Phase Ib ： SHR-1501 in combination with BCG or SHR-1316 dose escalation
* Phase II：SHR-1501 in combination with BCG or SHR-1316 dose expansion in NMIBC Receives: Drug: SHR-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: 21 Days
Maximum tolerated dose
Measured: Approximately 2years
Recommended Phase 2 dose (RP2D)
Measured: Approximately 2 years.
CR Rate (cohort 2)
Measured: Approximately 4 years.
12-month DFS Rate (cohort 1、3、4)
Measured: Approximately 4 years
Secondary outcomes (17)
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Measured: Approximately 4 years.
Duration of CR (DoR)
Measured: Approximately 4 years.
CR rate at 6 months and 18 months
Measured: Approximately 4 years.
DFS
Measured: Approximately 4 years.
Time to cystectomy,
Measured: Approximately 4 years.
Radical cystectomy rate;
Measured: Approximately 4 years.
The amount of drug recovered in perfusate and urine after SHR-1501 perfusion
Measured: Approximately 5 years.
Maximum concentration (Cmax) of SHR-1501
Measured: Approximately 2 years, if applicable
Time to maximum concentration (Tmax) of SHR-1501
Measured: Approximately 2 years，if applicable
Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501
Measured: Approximately 2 years，if applicable
Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1501
Measured: Approximately 2 years，if applicable
Half-life (t1/2) of SHR-1501
Measured: Approximately 2 years, if applicable
Apparent clearance (CL/F) of SHR-1501
Measured: Approximately 2 years, if applicable
Apparent volume of distribution (V/F) of SHR-1501
Measured: Approximately 2 years, if applicable
Concentration of SHR-1501 in Urine
Measured: Approximately 2 years, if applicable
Anti-drug antibody of SHR-1501
Measured: Approximately 2 years
Neutralizing antibody of SHR-1501
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start23 Nov 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk NMIBCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group .Dose escalation and expansion of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT05410730
- Sponsor's protocol ID
- SHR-1501-I-103
- Status last verified
- Jul 2024
- First submitted
- 19 May 2022
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of Dose Escalation and Dose Expansion of SHR-1501 Alone or in Combination With Bacille de Calmette Guerin （BCG） or SHR-1316 in the Treatment of Non-muscle Invasive Bladder Cancer（NMIBC）
- ClinicalTrials.gov ID
- NCT05410730
- Acronym / sponsor ID
- SHR-1501-I-103
- Conditions
- High-risk NMIBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jun 2022 (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 study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group .Dose escalation and expansion of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC
| Arm | Type | Receives |
|---|---|---|
| SHR-1501 | Experimental | Drug: SHR-1501* Phase I：Phase Ia and Ib： Phase Ia include SHR-1501 dose escalation and expansion; Phase Ib ： SHR-1501 in combination with BCG or SHR-1316 dose escalation * Phase II：SHR-1501 in combination with BCG or SHR-1316 dose expansion in NMIBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
- Age ≥ 18 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- Expected survival time ≥ 2 years;
- High-risk NMIBC diagnosed by previous pathological biopsy
Key exclusion criteria (19 listed)
- Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;
- Those who have previously received the following treatments and have not experienced disease progression before enrolment t as assessed by the investigator:
- Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
- Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
- Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
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-1501SHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316. | Drug | SHR-1501 |
Primary outcome
Dose-limiting toxicity
Time frame: 21 Days
Maximum tolerated dose
Time frame: Approximately 2years
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2 years.
CR Rate (cohort 2)
Time frame: Approximately 4 years.
12-month DFS Rate (cohort 1、3、4)
Time frame: Approximately 4 years
17 secondary outcomes
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Time frame: Approximately 4 years.
Duration of CR (DoR)
Time frame: Approximately 4 years.
CR rate at 6 months and 18 months
Time frame: Approximately 4 years.
DFS
Time frame: Approximately 4 years.
Time to cystectomy,
Time frame: Approximately 4 years.
Radical cystectomy rate;
Time frame: Approximately 4 years.
The amount of drug recovered in perfusate and urine after SHR-1501 perfusion
Time frame: Approximately 5 years.
Maximum concentration (Cmax) of SHR-1501
Time frame: Approximately 2 years, if applicable
Time to maximum concentration (Tmax) of SHR-1501
Time frame: Approximately 2 years，if applicable
Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501
Time frame: Approximately 2 years，if applicable
Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1501
Time frame: Approximately 2 years，if applicable
Half-life (t1/2) of SHR-1501
Time frame: Approximately 2 years, if applicable
Apparent clearance (CL/F) of SHR-1501
Time frame: Approximately 2 years, if applicable
Apparent volume of distribution (V/F) of SHR-1501
Time frame: Approximately 2 years, if applicable
Concentration of SHR-1501 in Urine
Time frame: Approximately 2 years, if applicable
Anti-drug antibody of SHR-1501
Time frame: Approximately 2 years
Neutralizing antibody of SHR-1501
Time frame: Approximately 2 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 28 Jan 2025.
- 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 1/2 study testing SHR-1501 in people with High-risk NMIBC, 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 9 inclusion and 19 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 28 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 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 Wenliang Wang (+0518-81220121, Wenliang.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: 21 Days). The study lists 5 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 28 Jan 2025.