RC48 antibody plus gemcitabine for high-risk bladder cancer
Part of Cancer, Kidney & urinary, Women’s health & pregnancy clinical trials.
This Phase 2 study tests RC48, an antibody-based drug, combined with gemcitabine to treat high-risk, non-muscle invasive bladder cancer that has not responded well to BCG or cannot receive BCG. It may help shrink tumors and reduce the chance of the cancer coming back.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be 18 years or older and sign the consent form (of your own free will).
- Have high-risk non-muscle invasive bladder cancer that has not spread to muscle or beyond the bladder (no distant spread) and may include certain high-risk features like T1 tumors, high-grade tumors, multiple/recurrent tumors, or carcinoma in situ (CIS).
- Have had TURBT (a procedure to remove bladder tumors) and all visible tumors were removed within the last 3 weeks.
- Have had prior BCG treatment, and either (a) could not receive enough BCG in the past for specific reasons, or (b) the cancer did not respond to BCG based on defined timing and test results.
- Your tumor tissue from TURBT must show HER2 positivity on a lab test (by immunohistochemistry) done at the study site.
- You must be well enough to take study treatment (acceptable blood counts and organ function) and have a heart pumping function test within the allowed range (ejection fraction ≥ 50%), plus an overall health score of 0–2.
- Agree to use reliable birth control (if applicable) and have a negative pregnancy test if you can become pregnant.
- Agree to follow the study visits and procedures, and you can’t have had certain other cancer treatments recently (with limited exceptions around the TURBT period).
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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