In short
IDE-161 is an investigational oral drug being developed as a potential cancer treatment. It is a small molecule that blocks an enzyme called poly ADP ribose glycohydrolase (PARG). The first clinical trial of IDE-161 in humans is a Phase 1 study in people with solid tumours, including small cell lung cancer, which is authorised to enrol up to 208 participants.
Key points
- IDE-161 is an investigational oral drug, not yet approved as a medicine.
- It belongs to the class of antineoplastics (cancer drugs) and is a small molecule.
- Its mechanism of action is PARG inhibition, which may stop cancer cells from repairing their DNA.
- The first clinical trial is a Phase 1 study in solid tumours, including small cell lung cancer.
- The trial is authorised and plans to enrol 208 participants.
- In this trial, IDE-161 is given orally, while the main study drug IDE849 is given intravenously.
What is IDE-161?
IDE-161, also written as IDE 161, is an investigational substance being developed by IDEAYA Biosciences as a potential cancer treatment. It is not yet an authorised medicine. IDE-161 is classified as an antineoplastic, meaning a drug that acts against tumours, and it is a small molecule, which means it is a chemically synthesised substance with a low molecular weight. It is considered a new molecular entity, meaning its active structure has not previously been approved in a medicine. IDE-161 does not have orphan drug designation, a status given to drugs for rare diseases.
How does IDE-161 work?
IDE-161 works by inhibiting an enzyme called poly ADP ribose glycohydrolase, or PARG. PARG is involved in the repair of damaged DNA inside cells. By blocking PARG, IDE-161 is thought to prevent cancer cells from repairing their DNA, which may lead to cancer cell death. This mechanism of action places IDE-161 in the class of PARG inhibitors.
Which conditions is it used or studied for?
IDE-161 is not authorised for any condition. It is being studied in clinical trials for the following conditions:
- Solid tumours — a broad group of cancers that form solid masses in organs or tissues, rather than affecting the blood or bone marrow.
- Small cell lung cancer — a fast-growing type of lung cancer that often spreads early.
- DLL3 expressing tumours — tumours that carry a protein called DLL3 on their surface, which is found in many small cell lung cancers and some other cancer types.
How is IDE-161 given?
In the registered clinical trial, IDE-161 is given orally, meaning by mouth. The trial record lists IDE-161 as an oral drug, in contrast to the main study drug IDE849, which is given by intravenous injection, and IMFINZI (durvalumab), which is given as an intravenous infusion. No specific formulation details such as tablet or capsule are stated in the available sources.
What do the clinical trials show?
One clinical trial of IDE-161 is registered. It is a Phase 1 study, which means it is the first stage of testing in humans and focuses mainly on safety, tolerability and finding an appropriate dose. The trial is authorised, meaning it has received the necessary approvals to begin, and it plans to enrol 208 participants.
The study investigates IDE849, a drug that targets DLL3, in people with DLL3 positive cancers, including small cell lung cancer. IDE-161 is included in the trial as an oral drug given in combination with IDE849. The main goals are safety endpoints: the incidence of dose-limiting toxicities, which are side effects that prevent further dose increases, and the incidence and severity of adverse events and serious adverse events, graded according to CTCAE version 5.0, a standard scale for reporting side effects in cancer trials. The trial also measures efficacy endpoints: objective response rate, meaning the proportion of participants whose tumours shrink or disappear (complete response plus partial response), and duration of response, assessed according to RECIST version 1.1, a standard way of measuring tumour changes.
The study is divided into two parts. Part 1 tests increasing doses of IDE849, alone or with other drugs including IDE-161, to find the highest dose that is safe and well tolerated. Part 2 studies the safety and anti-tumour activity of IDE849, alone or in combination, at or below the safe doses found in Part 1.
What side effects are known?
No side effects of IDE-161 specifically have been reported in the available sources. The clinical trial is designed to collect information on side effects, including their number and severity, as a primary objective. Because IDE-161 is still in Phase 1 testing, its safety profile in humans is not yet established.