In short
IDE849 is an investigational drug being studied in a phase 1 clinical trial for cancers that express DLL3, including small cell lung cancer. The trial, authorised in the EU, is testing IDE849 alone and in combination with other drugs in up to 208 participants. Its main goals are to find a safe dose and to look for early signs of anti-tumour activity.
IDE849 is an investigational substance being studied in oncology. It is given by intravenous injection and is being tested in a phase 1 trial for DLL3-expressing tumours, including small cell lung cancer.
Key points
- IDE849 is an investigational drug with no marketing authorisation in these records.
- The single registered trial is a phase 1 study in DLL3-positive cancers, including small cell lung cancer.
- The trial plans to enrol up to 208 participants and is currently authorised.
- IDE849 is given by intravenous injection.
- The trial measures safety, dose-limiting toxicities, and early signs of tumour response.
What is IDE849?
IDE849 is an investigational drug that has not received marketing authorisation in the records provided. It is being developed for the treatment of cancers that express the protein DLL3, a marker found on the surface of some tumour cells, including those of small cell lung cancer. The substance is studied as an intravenous injection.
How does IDE849 work?
The registry record does not describe the molecular mechanism of IDE849. The trial focuses on DLL3-positive tumours, which suggests the drug is intended to target cells carrying this protein, but no further mechanistic detail is provided in the data.
Which conditions is IDE849 being studied for?
- DLL3-expressing tumours — cancers whose cells carry the DLL3 protein on their surface.
- Small cell lung cancer — a fast-growing form of lung cancer that often expresses DLL3.
The trial includes these conditions together, as DLL3 expression is the main entry criterion.
How is IDE849 given?
IDE849 is given by intravenous injection. In the trial, it is studied alone and in combination with IDE161, an oral drug, and with IMFINZI (durvalumab), a concentrate for solution for infusion given intravenously.
What do the clinical trials show?
One phase 1 trial is registered for IDE849. The study is authorised and plans to enrol up to 208 participants with DLL3-positive tumours, including small cell lung cancer.
What is the trial measuring?
The primary safety endpoints are the incidence of dose-limiting toxicities and the incidence and severity of adverse events and serious adverse events, graded according to CTCAE version 5.0. Efficacy endpoints include objective response rate (ORR) — the proportion of participants whose tumours shrink or disappear — and duration of response (DOR), assessed by the investigator using RECIST version 1.1.
Who can take part in the trial?
The trial is designed for patients with DLL3-expressing tumours, including small cell lung cancer. The registry record does not list additional eligibility criteria such as age limits or prior treatments.
What side effects are known?
The registry record for this trial does not report specific side effects of IDE849. The trial is designed to measure the incidence and severity of adverse events and serious adverse events, so safety data will come from the study itself.