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AzTrials

NMIBCPhase 1/2NCT06588179

SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt

A Phase 1/2 study testing SHR-1501+SHR-2005 in people with NMIBC, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NMIBC
What is being tested?
SHR-1501+SHR-2005
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
1 Oct 2024to 1 Oct 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

  • Age ≥18 years old, both genders
  • Previous pathological biopsy was diagnosed as high-risk NMIBC
  • Tumors cannot be completely resected by TURBT（at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected）
  • Ineligible or unwilling to undergo radical cystectomy
  • TURBT was performed within 6 weeks
  • Agreed to provide cystoscopic biopsy specimens for review
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  • ECOG performance status of 0-2
  • Life expectancy ≥ 2 years
  • Adequate organ function：
  • Hematological indexes: ANC ≥1.5x10^9/L, PLT ≥100x10^9/L, Hb ≥ 90 g/L;
  • Liver function: TBIL ≤1.5 ULN; ALT and AST≤2.5 ULN; Albumin > 3g/dL
  • Renal function: Cr≤1.5 ULN or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); if proteinuria ≥++, requiring 24-hour urine protein level ≤1.0g;
  • ECG: females QTcF ≤470ms and males ≤450ms
  • Cardiac ultrasound: LVEF≥50%
  • Coagulation: INR or PT ≤1.5 ULN，APTT≤1.5 ULN
  • Female or male subjects of childbearing age who have not undergo surgical sterilization shall agree to 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 both female subjects and female partners of male subjects should use highly effective contraceptive methods; the Female subjects of childbearing age who have not undergone surgical sterilization must have a negative serum HCG test result within 7 days prior to the first administration and must be non-lactating.
  • Volunteered to join the study, signed the informed consent, and had good compliance with follow-up

Who cannot join

  • Previous pathological biopsy was diagnosed with muscle-invasive bladder cancer at T2 or higher stages
  • Received any other intravesical chemotherapy treatment within 2 weeks or received any other clinical drugs within 4 weeks
  • History of allergy to any of the study drugs or study drug components
  • Upper urinary tract tumor detected by CTU or MRU during screening period or other concomitant malignant tumors within 5 years before the first administration
  • Previously received any TNFR agonist antibody therapy(such as OX40, CD27, CD357 antibodies), IL-15 agonist antibody therapy, or IL-2 agonist antibody therapy
  • Oversize surgery or severe trauma within 4 weeks before the first use of research drugs
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  • Previously discontinued bladder instillation therapy due to adverse reactions such as sepsis, systemic infection, or urinary incontinence
  • Active/uncontrolled impairment of the urogenital system, kidneys, liver, gallbladder, cardiovascular system, gastrointestinal tract, nervous system, or hematopoietic system, which may lead to complications for the subject when receiving intravesical therapy and/or general anesthesia
  • A history of interstitial lung disease or non-infectious pneumonitis requiring treatment with glucocorticoids, or current presence of interstitial pneumonitis or non-infectious pneumonitis, or a history of other severe pulmonary diseases
  • A history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or current use of immunosuppressants
  • History of clinically significant cardiovascular disease within 6 months before the first administration
  • Investigator-assessed concern for medication safety; severe infections requiring antibiotic, antiviral or antifungal drug control; and unexplained fever > 38.5°C within 2 weeks
  • 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)
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade≤1 per NCI-CTCAE v5.0
  • The presence of any other conditions that the investigator deems inappropriate to participate in this study, including 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dingwei Ye, MD contact

86-21-64175590

dwyeli@163.com

Xiaolin Lu, MD contact

86-21-64175590

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, MD, 86-21-64175590

    Xiaolin Lu, MD, 86-21-64175590

Other trials in China

About this study

Official title: Phase Ib/II Clinical Study of SHR-1501 Combined With SHR-2005 in the Treatment of Patients With High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt

This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).

Conditions
NMIBC
Being tested
SHR-1501+SHR-2005
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1501+SHR-2005Drug

    SHR-1501, instillation；SHR-2005, instillation

Study groups in NCT06588179
Study groupRoleWhat they receive
Arm：SHR-1501+SHR-2005ExperimentalNot described
Receives: Drug: SHR-1501+SHR-2005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I : Incidence of dose limiting toxicities (DLTs)

    Measured: From Day 1 to Day 21

  2. Phase I : RP2D（Recommended Phase 2 dose）

    Measured: From Day 1 to 90 days after last dose

  3. Phase I : Incidence and severity of adverse events (AEs)

    Measured: From Day 1 to 90 days after last dose

  4. Phase II : CR rate at 3 months

    Measured: Approximately 2 years

Secondary outcomes (6)

  1. Phase I : CR rate at 3 months

    Measured: From Day 1 to 90 days after last dose

  2. Phase II : Incidence and severity of adverse events (AEs)

    Measured: Approximately 2 years

  3. Phase Ib/II: PR rate at 3 months

    Measured: Approximately 2 years

  4. Phase Ib/II: CR rate at 6 months and 12months

    Measured: Approximately 2 years

  5. Phase Ib/II: Duration of CR (DoR)

    Measured: Approximately 2 years

  6. Phase Ib/II: Cystectomy-Free Survival (CFS)

    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.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588179
Sponsor's protocol ID
NMIBC-NCR01
Status last verified
Sep 2024
First submitted
5 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1501+SHR-2005 in people with NMIBC, run by Fudan University 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 17 inclusion and 15 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: opening soon, as of the sponsor's last update on 19 Sep 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 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 Dingwei Ye, MD (86-21-64175590, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I : 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?

On the ClinicalTrials.gov record for NCT06588179.

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 19 Sep 2024.

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