Trials / Recruiting
RecruitingNCT07174583
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- Sponsor
- IDEAYA Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
Detailed description
This multicenter, open-label, Phase 1/2 study is designed to further characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of IDE849, an anti-DLL3 antibody-drug conjugate, alone and in combination with durvalumab or IDE161, in subjects with DLL3-expressing tumors including small-cell lung cancer (SCLC), high-grade neuroendocrine carcinomas (NEC), and other DLL3-positive solid tumors. Part 1 (Dose Escalation): Part 1A will evaluate IDE849 monotherapy, and Part 1B will evaluate IDE849 in combination with durvalumab or IDE161. This phase is designed to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE), in subjects with extensive-stage SCLC, high-grade NEC, or other DLL3-expressing tumors. Part 2 (Dose Expansion): Part 2 further will evaluate IDE849 alone or in combination at selected dose levels to characterize safety, PK, immunogenicity, and preliminary anti-tumor activity in defined cohorts of subjects with extensive-stage SCLC, high-grade NEC, or other DLL3-expressing tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDE849 | IV administration |
| DRUG | durvalumab | IV administration |
| DRUG | IDE161 | oral administration |
Timeline
- Start date
- 2025-10-14
- Primary completion
- 2029-05-01
- Completion
- 2029-05-01
- First posted
- 2025-09-16
- Last updated
- 2026-01-23
Locations
39 sites across 7 countries: United States, Australia, Brazil, Canada, Japan, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07174583. Inclusion in this directory is not an endorsement.