Table 2.
Clinical Trials for BTC Targeted Therapy Targeting IDH Mutations
| Target | Drugs | ClinicalTrials.gov Identifier | Status | Phase | Disease | Number of Patients | Design |
|---|---|---|---|---|---|---|---|
| IDH 1/2 | AG-120 (ivosidenib) | NCT02073994 | Active, not recruiting | I | CCA, Other solid tumors | 170 | AG-120 |
| NCT02989857 | Active, not recruiting | III | CCA with IDH1 mutations | 186 | AG-120 vs Placebo | ||
| NCT04088188 | Not yet recruiting | I | CCA | 40 | Ivosidenib plus GEMCIS vs Pemigatinib plus GEMCIS | ||
| Olutasidenib (FT-2102) | NCT03684811 | Recruiting | I II |
BTC, Hepatocellular Carcinoma | 200 | FT-2102 plus Nivolumab (Hepatobiliary tumors) FT-2102 plus GEMCIS (iCCA) | |
| IDH-305 | NCT02381886 | Active, not recruiting | I | Advanced malignancies with IDH1-R132 mutations | 166 | IDH-305 | |
| AG-221 | NCT02273739 | Completed | I II |
iCCA, Other solid tumor types with IDH2 mutations | 21 | AG-221 | |
| Dasatinib | NCT02428855 | Completed | II | CCA | 8 | Dasatinib | |
| PARPi | Olaparib (Lynparza) | NCT03212274 | Recruiting | II | CCA, Other solid tumor types with IDH1/IDH2 mutations | 145 | Olaparib |
| NCT04306367 | Recruiting | II | CCA | 29 | Olaparib plus Pembrolizumab | ||
| NCT04298021 | Not yet recruiting | II | BTC | 74 | Olaparib plus AZD6738 vs Durvalumab plus AZD6738 | ||
| Rucaparib | NCT03639935 | Recruiting | II | BTC | 35 | Rucaparib plus Nivolumab | |
| NCT03337087 | Active, not recruiting | I II |
BTC Other solid tumor types | 110 | Rucaparib plus Nal-IRI plus Leucovorin plus Fluorouracil | ||
| Niraparib | NCT03207347 | Recruiting | II | CCA, Other solid tumor types | 57 | Niraparib |