Drugs / IDE849
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07174583 | Oct 2025 → Jul 2029 expected | small cell lung carcinoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer ideayabio.com ↗
IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a potential best-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC), in extensive stage small cell lung cancer (ES-SCLC). |
| 2025-09-16 | Jiangsu HengRui Medicine Co., Ltd. | Results 2025 WCLC口头报告｜恒瑞创新药SHR-4849在复发性小细胞肺癌患者中的首次人体Ⅰ期研究结果披露 hengrui.com ↗
结果显示 [1] ，SHR-4849在复发性小细胞肺癌患者中展现出可耐受且可控的安全性特征。 |
| 2025-09-07 | IDEAYA Biosciences | Results IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer ideayabio.com ↗
80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849 |
| 2025-05-06 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors ideayabio.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IDE849 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07174583 ↗ |
| Route | Intravenous | “IV administration” NCT07174583 ↗ |
| Target | DLL3 | “an anti-DLL3 antibody-drug conjugate” NCT07174583 ↗ |