AB-218 Safety and Efficacy Study in Patients With IDH1 Mutant Glioma
Status:
Not yet recruiting
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multicenter, open label, two part, clinical study to evaluate the
efficacy, safety, and PK of AB 218 in participants with recurrent or progressive
histologically confirmed IDH1 mutant WHO Grade 2/3 glioma outside Japan. It was divided into
2 parts. Part 1 includes two stages: stage 1 and stage 2. Stage 1 further explores 5 dosing
regimens in the glioma patients outside Japan. Stage 2 is dose expansion with one selected
dosing regimen on non-surgical patients and surgical participants. The PK characteristics,
safety and initial efficacy data will be assessed in Part 1. Part 2 is to evaluate the
efficacy of AB-218 in the treatment of recurrent/progressive WHO CNS Grade 3 IDH1 mutant
glioma.
Participants will receive oral AB-218 treatment continuously, with 28 days as a cycle, until
disease progression, unacceptable toxicity, consent withdrawal, start of new anti-cancer
therapy, investigator decision or death, upon whichever earlier.
Besides baseline, the anti-tumor response will be evaluated every 8 weeks following RANO or
RANO-LGG criteria as applicable, until disease progression, consent withdrawal or death, upon
whichever earlier.