An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

Phase 2 Recruiting 300 enrolled Peking Union Medical College Hospital

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a multicenter, non-randomized, umbrella, open-label phase II clinical study, aiming to observe and evaluate, as well as explore the efficacy and safety of precision targeted therapy based on NGS technology for IDH1-mutated patients, specifically the combination of ivosidenib with multi-target tyrosine kinase inhibitors represented by lenvatinib or PD-1/PD-L1 in advanced biliary tract cancer patients who have failed systemic chemotherapy.

Timeline

Start: 2024-05-01
Primary completion: 2026-10-01
Completion: 2026-10-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	—	Intravenous
Subject	Ivosidenib	Small molecule	500 mg	Oral
Subject	Lenvatinib	Small molecule	8 mg	Oral
Subject	Lenvatinib	Small molecule	12 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	—	Intravenous
Subject	Tislelizumab	Monoclonal antibody	—	Intravenous
Subject	Toripalimab	Monoclonal antibody	—	Intravenous

An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

Summary

Timeline

Drugs

Indications