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New hope for advanced bladder cancer patients who have run out of options

NCT ID NCT07129993

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study is for people with advanced bladder cancer that has gotten worse after standard treatment. It tests a new drug combination (datopotamab deruxtecan plus chemotherapy) against another chemotherapy combo. The goal is to see if the new combo can shrink tumors or slow the cancer's growth. About 630 adults will take part worldwide.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 630 people

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

Started

Sep 2025

Expected to finish

Jan 2030

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.

Key Inclusion Criteria: * Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \> 18 years old, then follow the local regulatory requirements). * Histologically or cytologically confirmed unresectable or locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible if the histology is predominantly urothelial as specified in the protocol. * Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing. Tumor tissue sample should not be collected from a lesion that was irradiated unless documentation can be provided confirming that the tumor tissue was collected at least 3 months after radiation and the lesion increased/appeared since radiation occurred. Tumor tissue must be of sufficient quantity (as defined in the Laboratory Manual). * Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred. * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. Participants eligible for cisplatin will receive cisplatin. If a participant received gemcitabine, carboplatin, or cisplatin for early UC in the adjuvant/neoadjuvant setting, the decision to rechallenge the participant with platinum therapy will be at the discretion of the investigator. Participants only receive carboplatin if they are ineligible for cisplatin. Participants are cisplatin-ineligible if they meet any of the following criteria: a. GFR \<60 mL/min (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine) For Phase 2 part: * Participants with a GFR \<60 mL/min but ≥50 mL/min but have no other cisplatin ineligibility criteria (items b, c, and d) may be considered cisplatin-eligible based on the investigator's clinical judgment. For Phase 3 Part: * Participants with borderline renal function CrCl ≥40 mL/min to \<60 mL/min who have no other cisplatin ineligibility criteria (items b, c, and d) may receive cisplatin using a split-dose regimen, administered as cisplatin 35 mg/m\^2 on Days 1 and 8 of each 21-day cycle, for a maximum of 4 to 6 cycles. * In participants with CrCl ≥50 mL/min to \<60 mL/min, full-dose cisplatin may also be administered at the investigator's discretion, based on the overall clinical assessment. The dosing schedule and dose level for Dato-DXd or gemcitabine are not altered when combined with either split-dose or full-dose cisplatin. For both Phase 2 and Phase 3: b. NCI-CTCAE Grade ≥2 audiometric hearing loss c. NCI-CTCAE Grade ≥2 peripheral neuropathy d. NYHA Class III heart failure • Must have experienced radiographic progression or relapse during or after 1L of EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1/PD-L1 inhibitors). Participants who discontinued EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1/PD-L1 inhibitors) in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation. Participant who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1/PD-L1) inhibitors in a neoadjuvant/adjuvant setting and progressed during treatment or within 12 months of treatment completion will also be considered for enrollment, after approval by the Sponsor's Medical Monitor or Sponsor's designee. Key Exclusion Criteria: * Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC. The following participants may be considered eligible after approval by the Sponsor's Medical Monitor or Sponsor's designee. * Participant who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule inhibitors) combined with PD1/PD-L1 inhibitors in 1L la/mUC. * Treatment with any of the following: 1. History of an allogeneic bone marrow or solid organ transplant. 2. Concomitant treatment with any prohibited medications in this protocol. 3. Prior TROP2 directed ADC therapy. * Uncontrolled or significant cardiovascular disease, including: QTcF interval \>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening. 1. Screening myocardial infarction within 6 months prior to randomization. 2. Uncontrolled angina pectoris within 6 months prior to randomization. 3. NYHA Class 3 or 4 congestive heart failure at screening. 4. Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy). * Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior complete pneumonectomy. * Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \>2 for at least 3 months prior to randomization and managed with standard of care treatment) which the investigator deems related to previous anticancer therapy, comprised of (including but not limited to): a. Anticancer therapy-induced neuropathy b. Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies which may include: * Hypothyroidism/ hyperthyroidism * Type I diabetes * Hyperglycemia * Adrenal insufficiency * Adrenalitis c. Skin hypopigmentation (vitiligo)

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Urothelial cancer

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

    29 sites in 5 countries. 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

  • Research Site

    ACTIVE_NOT_RECRUITING

    Fullerton, California, 92835, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Glendale, California, 91204, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92093, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90024, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94158, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Aurora, Colorado, 80012, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Orange City, Florida, 32763, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Tamarac, Florida, 62269, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30342, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Locust Grove, Georgia, 30248, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Effingham, Illinois, 62401, United States

  • Research Site

    RECRUITING

    Niles, Illinois, 60714, United States

  • Research Site

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Largo, Maryland, 20774, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02216, United States

  • Research Site

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    New York, New York, 10029, United States

  • Research Site

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97227, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Providence, Rhode Island, 02906, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Germantown, Tennessee, 38138, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Memphis, Tennessee, 38120, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 33322, United States

  • Research Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75390, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Research Site

    RECRUITING

    Norfolk, Virginia, 23502-1871, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Spokane, Washington, 99208, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Madison, Wisconsin, 53715, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Graz, 8036, Austria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Krems, Austria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Linz, 4010, Austria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Salzburg, 5020, Austria

  • Research Site

    ACTIVE_NOT_RECRUITING

    Vienna, Austria

  • Research Site

    RECRUITING

    Beijing, 100142, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Chengdu, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Guangzhou, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Angers, 49055, France

  • Research Site

    RECRUITING

    Bordeaux, 33075, France

  • Research Site

    RECRUITING

    Brest, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Calais, France

  • Research Site

    RECRUITING

    Cedex 10, France

  • Research Site

    RECRUITING

    Créteil, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Grenoble, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    La Chaussée-Saint-Victor, France

  • Research Site

    RECRUITING

    La Roche-sur-Yon, France

  • Research Site

    RECRUITING

    Le Mans, France

  • Research Site

    RECRUITING

    Lyon, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Marseille, 13273, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Marseille, France

  • Research Site

    RECRUITING

    Montpellier, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Nantes, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Nîmes, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Research Site

    RECRUITING

    Paris, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Pierre-Bénite, 69310, France

  • Research Site

    RECRUITING

    Poitiers, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Quint-Fonsegrives, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Reims, France

  • Research Site

    RECRUITING

    Saint-Etienne, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Saint-Herblain, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Strasbourg, 67065, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Toulouse, France

  • Research Site

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Research Site

    ACTIVE_NOT_RECRUITING

    Eisleben Lutherstadt, 06295, Germany

  • Research Site

    ACTIVE_NOT_RECRUITING

    Herne, 44625, Germany

  • Research Site

    RECRUITING

    Nürtingen, Germany

  • Research Site

    ACTIVE_NOT_RECRUITING

    Stuttgart, 70174, Germany

  • Research Site

    ACTIVE_NOT_RECRUITING

    Naples, Italy

  • Research Site

    ACTIVE_NOT_RECRUITING

    Roma, Italy

  • Research Site

    ACTIVE_NOT_RECRUITING

    Rozzano, Italy

  • Research Site

    ACTIVE_NOT_RECRUITING

    Bunkyō City, 113-8519, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Bunkyō City, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Fukuoka, 812-8582, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Fukuoka, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hirosaki-shi, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Kanazawa, Japan

  • Research Site

    RECRUITING

    Kawasaki, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Kumamoto, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Kyoto, 606-8507, Japan

  • Research Site

    RECRUITING

    Nagoya, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Niigata, Japan

  • Research Site

    RECRUITING

    Okayama, 700-8558, Japan

  • Research Site

    RECRUITING

    Osaka, Japan

  • Research Site

    RECRUITING

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Sapporo, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Shinjuku-ku, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Toyama, Japan

  • Research Site

    ACTIVE_NOT_RECRUITING

    Tsukuba, 305-8576, Japan

  • Research Site

    RECRUITING

    Ube-shi, 755-8505, Japan

More trials for these conditions

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