Study of a new targeted drug for advanced solid tumors with HER2
Part of Cancer clinical trials.
This study tests a new antibody-drug conjugate (FDA022-BB05) for people with advanced solid cancers—especially breast, endometrial, bladder, colorectal, or lung cancer—that have stopped responding to standard therapy. The drug targets HER2, a protein on some cancer cells, to try to shrink tumors or slow their growth.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have advanced cancer that has spread or cannot be removed by surgery and has not responded to or is not suitable for standard treatments.
- Your type of cancer must fit into one of these groups: low-HER2 breast cancer, HER2-expressing endometrial cancer, or another cancer like bladder, colorectal, or lung with HER2 overexpression or mutation.
- Your heart function must be strong (ejection fraction at least 50% on a recent scan) and you must not have had heart failure or serious heart rhythm problems.
- You cannot have had a previous antibody-drug conjugate that uses a topoisomerase I inhibitor (like certain types of chemotherapy-linked antibodies).
- You must be in generally good daily function (able to take care of yourself and out of bed more than half the day) and expected to live at least 3 more months.
- You cannot have untreated brain metastases that are causing symptoms or need steroids, nor severe lung disease called interstitial lung disease.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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