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Can a Two-Drug attack shrink Hard-to-Treat bladder tumors?

NCT ID NCT06405425

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase II trial is testing whether combining an experimental drug called BL-B01D1 with a PD-1 inhibitor can shrink tumors in people with advanced or metastatic urothelial carcinoma (a type of bladder cancer) who have not had prior systemic therapy. The study will measure how many patients respond to the treatment and how long they live without the cancer growing. About 52 participants will receive the drug combination intravenously every three weeks.

What this could mean

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

Active substance
a combination of an experimental drug called BL-B01D1 (izalontamab brengitecan) and a PD-1 inhibitor
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced bladder cancer who have not yet received systemic therapy.
What could go wrong
This is an early-phase trial with only 52 participants, so results may not apply broadly. The combination may cause significant side effects, and it is not yet known if it will work better than existing treatments.
Why investors are watching

Sichuan Baili Pharmaceutical is running a phase II trial of BL-B01D1 combined with a PD-1 inhibitor in 52 patients with advanced urothelial carcinoma, a type of bladder cancer. For a small company, this readout tests whether its drug combination can control the disease, and the result will shape its pipeline value and future development plans.

If it works: A positive result could show the combination shrinks or stabilizes tumors, which may support further trials and partnerships. That outcome would validate the company's lead drug candidate and strengthen its position in cancer treatment.

If it fails: A failure or delay could set back the drug's development and hurt the company's prospects, since it relies on this candidate. Trials often fail to meet their goals, so a negative readout is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 52 people

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

Started

May 2024

Expected to finish

Jun 2028

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 to 75 years

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. All subjects voluntarily participated in the study and signed informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG 0-1; 5. Unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and/or cytology; 6. Participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer; 7. A biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for PD-L1 and other testing; 8. At least one measurable lesion meeting the RECIST v1.1 definition was required; 9. The level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and/or platelet-raising drugs are not allowed within 14 days before the first dose; 10. Previous treatment-related toxicity returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior ADC recipients with TOPI inhibitors as toxin; 2. Palliative radiotherapy within 2 weeks before the first dose; 3. Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis; 4. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Active autoimmune and inflammatory diseases; 8. Receiving \&gt before the first dose; Long-term systemic corticosteroid therapy with prednisone 10mg/d; 9. Other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. History of ILD, current ILD, or suspected ILD; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; Infusion-related thrombosis was excluded; 14. Patients with active central nervous system metastases; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. Participated in another clinical trial within 4 weeks before the first dose; 21. Patients with superior vena cava syndrome should not be rehydrated; 22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

More trials for these conditions

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