IDE849 (DLL3-targeted ADC) ± Durvalumab in DLL3+ Tumors
A Study of IDE849 in Patients with DLL3 Expressing Tumors Including Small Cell Lung Cancer
IDENTIFIER (ClinicalTrials.gov): NCT07174583
DRUG/TREATMENT: IDE849, an anti-DLL3 antibody-drug conjugate
PHASE: 1/2
STATUS: Recruiting
SPONSOR: IDEAYA Biosciences
DESCRIPTION:
This is a Phase 1/2, multi-center clinical trial studying a new treatment called IDE849 in people with DLL3-expressing cancers, including small cell lung cancer (SCLC), high-grade neuroendocrine carcinomas (NECs), and other solid tumors.
What is DLL3?
DLL3 (delta-like ligand 3) is a protein found on the surface of some cancer cells, especially high-grade neuroendocrine cancers. Because DLL3 is much less common on normal cells, it has become an important target for new cancer treatments.
What is IDE849?
IDE849 is an antibody-drug conjugate (ADC), a newer type of targeted cancer therapy.
ADCs combine:
an antibody, which acts like a homing device to find cancer cells with a specific marker (like DLL3), and
a drug payload (often a chemotherapy-like agent) that is delivered directly to those cells
IDE849 is designed to find DLL3-positive cancer cells and deliver a cancer-fighting drug directly to them, which may help kill cancer cells while limiting damage to healthy tissue.
In this study, IDE849 is being tested:
on its own, and
in combination with other treatments, including durvalumab (an immunotherapy) or another investigational drug (IDE161)
About the Study
Researchers want to understand:
Safety and side effects
How well the treatment works
How the drug moves through and affects the body (pharmacokinetics and immunogenicity)
The best dose to use in future studies
How the Study is Structured
Part 1 (Dose Escalation):
Participants receive increasing doses of IDE849 (alone or in combination)
The goal is to find the safest and most effective dose
Part 2 (Dose Expansion):
Participants receive the selected dose(s)
Researchers further evaluate safety and early effectiveness in specific groups of patients
Who This Study Is For
This study is enrolling people with:
Small cell lung cancer (SCLC)
High-grade neuroendocrine carcinomas (NECs)
Other solid tumors that express DLL3
Why This Matters
Treatment options for high-grade neuroendocrine carcinomas (NECs) and small cell lung cancer (SCLC) are often limited, especially after standard therapies stop working.
DLL3-targeted therapies like IDE849 represent a promising new approach because they are designed to specifically target cancer cells that carry the DLL3 marker. By delivering treatment directly to these cells, this strategy may improve effectiveness while limiting damage to healthy tissue.
This study is also exploring combination approaches, including immunotherapy, which may further enhance how well treatment works.
If successful, this research could help expand treatment options for patients with DLL3-positive cancers, including those beyond small cell lung cancer.
CONTACT
For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here.
Name: IDEAYA Clinical Trials
Phone Number: +1-855-433-2246
Email: IDEAYAClinicalTrials@ideayabio.com
This is a multicenter trial with various locations. Go to the “Contacts and Locations” section of this trial page at ClinicalTrials.gov for site-specific contact information.