IOA-289-102
Research type
Research Study
Full title
A Phase 1b, open label, dose escalation study of IOA-289, an orally bioavailable, selective autotaxin (ENPP2) inhibitor alone and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer.
IRAS ID
1005231
Contact name
Michael Lahn
Contact email
Sponsor organisation
iOnctura S.A.
Eudract number
2022-000414-33
Clinicaltrials.gov Identifier
Research summary
This study is designed to collect information on the safety and tolerability of an experimental drug called IOA-289 in pancreatic cancer patients in combination with the chemotherapies gemcitabine and nab-paclitaxel.
The autotaxin (ATX) protein produces lysophosphatidic acid (LPA). LPA is involved in the growth, movement, and survival of many cell types, including cancer cells. IOA-289 is a novel ATX inhibitor and can potentially block cancer cell growth, movement, and survival. However, its role in pancreatic tumours has not been well investigated. The purpose of the study is to assess if IOA-289 can be safely administered to patients, examine how the drug is changed by and removed from the body and if it provides additional benefits for the treatment of pancreatic cancer. This is an open-label and dose-escalation study.
This study will involve approximately 24 patients globally. The study consists of a Screening period (up to 28 days), a Lead in period (7 days), a Study treatment period (Cycles with a minimum of 28 days), and a Follow-up period (12 weeks). This study will have approximately 4 study visits over a period of every 28 days/1 Cycle during the Study treatment period. The minimum total time spent in the study is estimated to be 25 weeks.Participants will be assigned to one of 4 groups receiving with 200mg, 400mg, 800mg or 1200mg of IOA-289. IOA-289 will be taken orally 2 times a day on a 28-day cycle with water on an empty stomach. The first 7 days will be IOA-289 alone (Lead in period), after which all following Cycles will be the combination of IOA-289 and chemotherapies.
Participants will receive gemcitabine/nab-paclitaxel as an intravenous infusion once weekly for three times during a 28-day Cycle. Study staff will determine enrolment group, dose of IOA-289, and the amount of gemcitabine/nab-paclitaxel received. Additionally, the study staff will determine the number of treatment cycles for each participants during the treatment period.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0187
Date of REC Opinion
15 Sep 2023
REC opinion
Further Information Favourable Opinion