Plain-English translation of NCT06460298 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing a new medication called ProAgio combined with gemcitabine (a chemotherapy drug) in people with advanced triple-negative breast cancer who have already tried at least two other treatment approaches. The study has two phases: first, researchers will carefully increase the dose to find the safest and most effective dose level, then they will test that dose in more patients to see how well the medication works.
Triple-negative breast cancer is particularly difficult to treat because it doesn't respond to hormone therapy or certain targeted drugs. Doctors need new treatment options for patients whose cancer has spread and stopped responding to standard treatments, which is why this trial is exploring whether this medication can help.
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You will receive intravenous injections of the medication on days 1, 8, and 15 of each 4-week treatment cycle. During the first part of the study (dose escalation), the research team will gradually increase your dose to find the safest level; during the second part (dose expansion), more patients will receive the dose that worked best. You will need to provide tumor tissue samples before treatment starts and again during your second cycle of treatment, and you'll have regular blood tests and medical visits to monitor your health and how well the treatment is working.
AI-generated summary from trial data · Jun 18, 2026 · Not medical advice
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