IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor
Status:
Not yet recruiting
Trial end date:
2026-05-01
Target enrollment:
Participant gender:
Summary
This is an open label, single-arm Phase I study to evaluate the safety, tolerability, PK and
preliminary efficacy of AB-218, an oral IDH1 inhibitor, for the treatment of adult patients
with advanced IDH1 mutant cholangiocarcinoma and other solid tumors who have failed at least
one prior therapy in the advanced stage.
The study contains a dose escalation part and a dose expansion part. In the dose escalation
part, participants are enrolled sequentially into one of 3 dose levels of AB-218 (125 mg BID,
250 mg BID and 500 mg BID) following a 3+3 rule. Intensive PK sampling will be performed
during the dose escalation part. Participants will be followed up for DLTs from the date of
first study dose to 28 days afterwards. When all participants in the dose escalation part
have completed the 28-day DLT observation period, SMC will review the available data
including but not limited to safety, tolerability and PK, and then recommend the dose for the
study dose expansion part.
In the dose expansion part, there are 2 disease cohorts planned: cholangiocarcinoma (CCA) and
other IDH1 mutant solid tumors. It is planned to enrol 30 participants in the CCA cohort and
another 15 participants in other IDH1 mutant solid tumors, to assess the safety and
preliminary efficacy of AB-218. Sparse PK samples will be collected to further evaluate the
PK profile in the different target populations.
Each participant will undergo screening up to 28 days prior to the start of the treatment
period. The treatment period consists of a visit on Day 1 of every 28-day cycle and continues
until any of disease progression, unacceptable toxicity, withdrawal of consent or death. An
end of treatment (or early discontinuation) visit occurs 30 days (± 7 days) after the last
dose of study medication, and a survival follow call every 12 weeks until death, withdrawal
of informed consent, loss to follow-up (LTFU) or termination of the study by the sponsor,
whichever occurs first.