Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New biologic combo aims to spare bladders in cancer fight

NCT ID NCT07445308

Disease control Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new biologic drug called SPGL008, given alone or with the standard therapy BCG, in 120 people with high-risk non-muscle-invasive bladder cancer who are not candidates for bladder removal. The main goals are to find a safe dose and see if the drug can control the cancer. The study is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPGL008 (a biologic) alone or combined with BCG
What this could lead to
If successful, this could point toward a new treatment option for people with high-risk bladder cancer who cannot or choose not to have bladder removal surgery.
What could go wrong
This is an early-phase trial with only 120 participants, so it is too soon to know if SPGL008 works. Side effects are possible, and the combination with BCG may increase risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. ineligible or unwilling to undergo radical cystectomy; 7. The level of organ function is good. Exclusion Criteria: 1. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study; 2. 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; 3. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose; 4. Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration; 5. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators; 6. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for NMIBC are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NMIBC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.