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New drug duo takes on advanced bladder cancer in early trial

NCT ID NCT07636772

Disease control Sponsor: Akeso 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug called AK146D1, given alone or with another drug (AK112), in people with advanced urothelial carcinoma (a type of bladder cancer). The goal is to see if the treatment is safe and can shrink tumors. About 132 adults aged 18-75 with measurable tumors and good organ function may join.

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 132 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 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: * Be able to understand and voluntarily sign the written informed consent form. * Age 18-75. * ECOG PS 0 or 1. * Expected lifespan ≥3 months. * Histologically or cytologically documented Urothelial carcinoma. * At least one measurable lesion according to RECIST v1.1. * Sufficient organ function. Exclusion Criteria: * Having other active malignancies within 3 years. * Currently participating in another interventional clinical study. * Presence of active metastases to the central nervous system. * Prior chemotherapy agent targeting topoisomerase I . * Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose. * Patients with clinically significant cardiovascular or cerebrovascular diseases or risks. * Patients with active autoimmune diseases requiring systemic treatment within 2 years. * Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose. * Previous history of severe hypersensitivity reactions. * Patients with a history of mental illness and incapacitated or limited capacity. * Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial carcinoma (UC)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, China

More trials for these conditions

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