Drugs / ZL-1310
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07531095 | Apr 2026 → May 2028 expected | small cell lung carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT06179069 | Jan 2024 → May 2027 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07707895 | Oct 2026 → Apr 2030 expected | pulmonary large cell neuroendocrine carcinoma, small cell lung carcinoma | Boehringer Ingelheim | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06885281 | May 2025 → Aug 2027 expected | cancer | Zai Lab (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07796100 | Dec 2026 → Jun 2030 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07218146 | Nov 2025 → Jun 2028 expected | small cell lung carcinoma | Zai Lab (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-08-03 | Zai Lab (Shanghai) Co., Ltd. | Regulatory U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) zailaboratory.com ↗
U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs) |
| 2026-06-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs). |
| 2026-05-11 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Receives U.S. FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci), a DLL3-Targeting ADC, for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs) zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of extrapulmonary neuroendocrine carcinomas (epNECs) following progression after standard first-line therapy. |
| 2026-04-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Presents New Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Rapid and Robust Intracranial Responses in Small Cell Lung Cancer with Brain Metastases and Promising Activity in Other Neuroendocrine Carcinomas zailaboratory.com ↗
Zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, showed a 53.7% confirmed intracranial objective response rate (iORR) for small cell lung cancer (SCLC) with brain metastases; at 1.6 mg/kg dose, the confirmed iORR was 62.5% (10/16), including complete responses |
| 2026-03-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Present New Data on Three Internally Developed Oncology Candidates at AACR 2026, Including Zocilurtatug Pelitecan, a DLL3-Targeting Antibody-Drug Conjugate (ADC) zailaboratory.com ↗
Zoci data show intracranial response in small-cell lung cancer (SCLC) with brain metastases, as well as activity in other neuroendocrine carcinomas |
| 2025-10-24 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Updated Phase 1 Data for Zocilurtatug Pelitecan (formerly ZL-1310), Demonstrating Potential as a First-in-Class/Best-in-Class DLL3-Targeted ADC for Small Cell Lung Cancer, and Initiation of Global Phase 3 Registrational Study zailaboratory.com ↗
Robust responses observed in heavily pre-treated patients with a 68% ORR for 1.6 mg/kg in second-line setting |
| 2025-06-02 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Presents Positive Phase 1 Data for ZL-1310, a DLL3-Targeted ADC, Demonstrating Robust Anti-Tumor Activity and Safety in Patients with Extensive-Stage Small Cell Lung Cancer at 2025 ASCO Annual Meeting zailaboratory.com ↗
Zai Lab Presents Positive Phase 1 Data for ZL-1310, a DLL3-Targeted ADC, Demonstrating Robust Anti-Tumor Activity and Safety in Patients with Extensive-Stage Small Cell Lung Cancer at 2025 ASCO Annual Meeting |
| 2025-05-19 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer zailaboratory.com ↗ |
| 2025-01-22 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC) zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC). |
| 2024-11-12 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Third Quarter 2024 Financial Results and Recent Corporate Updates zailaboratory.com ↗
Findings from this study suggest that ZL-1310 delivers anti-tumor activity across multiple dose levels with an overall response rate of 74%. |
| 2024-10-24 | Zai Lab (Shanghai) Co., Ltd. | Results ZL-1310, an Investigational DLL3-Targeted Antibody-Drug Conjugate (ADC), Demonstrates Promising Objective Response Rates and Safety Profile in Extensive-Stage Small Cell Lung Cancer zailaboratory.com ↗
The ORR in patients with at least one post-treatment evaluation was 74% (95%CI, 48.8, 90.9). |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZL-1310 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06885281 ↗ |
| Route | Intravenous | “administered intravenously” NCT06885281 ↗ |
| Target | DLL3 | “ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC)” NCT07218146 ↗ |