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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC

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)

A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC (NCT05410730) is a Phase 1 / Phase 2 interventional studying High-risk NMIBC, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For High-risk NMIBC, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused High-risk NMIBC subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the willing to sign a consent form in writing; 2. Age ≥ 18 years old, gender is not limited; 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 4. Expected survival time ≥ 2 years; 5. High-risk NMIBC diagnosed by previous pathological biopsy 6. 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; 7. ineligible or unwilling to undergo radical cystectomy; 8. The level of organ function is good. 9. 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 Should NOT Join This Trial: 1. Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration; 2. 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. 3. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing; 2. Age ≥ 18 years old, gender is not limited; 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 4. Expected survival time ≥ 2 years; 5. High-risk NMIBC diagnosed by previous pathological biopsy 6. 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; 7. ineligible or unwilling to undergo radical cystectomy; 8. The level of organ function is good. 9. 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. Exclusion Criteria: 1. Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration; 2. 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. 3. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study; 4. 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; 5. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose; 6. Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration; 7. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators; 8. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment; 9. 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; 10. Active or history of interstitial lung disease; 11. History of clinically significant cardiovascular disease 12. A history of immunodeficiency, including HIV seropositive, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or those who are using immunosuppressants; 13. With a history of active autoimmune disease; 14. 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); 15. Known allergic or intolerance to study drug, BCG (Phase Ib and Phase II subjects only) or excipients; 16. 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.

Treatments Being Tested

DRUG

SHR-1501

SHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University First Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05410730), the sponsor (Shanghai Hengrui Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05410730 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05410730?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05410730?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05410730. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05410730. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.