Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer
A Prospective, Open-Label, Multicenter Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib for HER2-Positive or Low-Expression Locally Advanced or Metastatic Biliary Tract Cancer in the Second-Line or Later Setting
Peking Union Medical College Hospital
70 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
Summary
An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive/low-expressing biliary tract cancer after the failure of at least two prior systemic therapies.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The recommended dosage is 4.8 mg/kg. A fixed dose of 408 mg is administered for patients weighing ≥85 kg. It is given via intravenous infusion every 3 weeks (Q3W). The first infusion should be administered over 90 minutes. If the prior infusion was well-tolerated, subsequent infusions may be shortened to 30 minutes.
A fixed dose of 1200 mg is administered via intravenous infusion every 3 weeks (±3 days). The infusion duration should be controlled between 30 and 60 minutes and must not exceed 2 hours.
Administered orally once daily with food (preferably at the same time each day). The dose is 12 mg/day for patients weighing ≥60 kg and 8 mg/day for those \<60 kg. The dose can be de-escalated based on toxicity according to the following scheme: 12 mg/day → 8 mg/day → 4 mg/day → discontinuation. If the investigator deems the patient intolerant, dose reduction across levels may be considered if deemed necessary.
Locations(1)
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NCT07704177