New drug combo aims to tackle Hard-to-Treat cancers
NCT ID NCT05163041
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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START Center for Cancer Care
San Antonio, Texas, 78229, United States
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State University of Iowa
Iowa City, Iowa, 52242, United States
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The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
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The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors