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New drug combo aims to tackle Hard-to-Treat cancers

NCT ID NCT05163041

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called BT7480, given alone or with another drug (nivolumab), in 200 people with advanced solid tumors that have stopped responding to standard treatments. The main goals are to find a safe dose and see if the drug shrinks tumors. It is an early-stage trial, so results will show if further testing is worthwhile.

What this could mean

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

Active substance
BT7480 (a drug given by IV) and nivolumab (an immunotherapy drug)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 200 participants, so the drug may not prove effective or safe enough for wider use. Side effects are unknown and could be serious.

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 200 people

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

Started

Nov 2021

Expected to finish

Dec 2026

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: * Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator * Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma * Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function * Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Life expectancy ≥12 weeks * Must submit fresh or archival tumor tissue * Must provide written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analysis Exclusion Criteria: * Prior therapy with a cytotoxic, small molecule, or other systemic chemotherapy within 14 days of the first dose of study drug * Prior immunotherapy, including monoclonal antibodies, within 28 days or 5 half-lives of the first dose of study drug, whichever is shorter * Prior treatment with CD137 targeted therapy * Mean resting QTc (eg, QTcF) greater than 470 msec on triplicate electrocardiograms (ECGs) obtained at screening * Uncontrolled symptomatic brain metastases * Uncontrolled diabetes with glycosylated hemoglobin greater than or equal to 8% * Uncontrolled hypertension at screening or prior to initiation of study drug * History of autoimmune disease except well-controlled diabetes mellitus, alopecia, well controlled thyroid disease or vitiligo

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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.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • START Center for Cancer Care

    San Antonio, Texas, 78229, United States

  • State University of Iowa

    Iowa City, Iowa, 52242, United States

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

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