Drugs / BL-M14D1
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07080242 | Apr 2025 → Dec 2027 expected | cutaneous neuroendocrine carcinoma, prostate neuroendocrine neoplasm, pulmonary large cell neuroendocrine carcinoma, small cell lung carcinoma | SystImmune Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06505824 | Aug 2024 → Aug 2026 overdue | small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07654400 | Jul 2026 → Dec 2027 expected | small cell lung carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07625644 | Aug 2026 → Jan 2030 expected | small cell lung carcinoma | SystImmune Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M14D1（DLL3 ADC）联合用药治疗广泛期小细胞肺癌获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2026-06-09 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于BL-M14D1（DLL3 ADC）联合免疫治疗用于一线广泛期小细胞肺癌患者的III期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2026-06-01 | SystImmune Inc. | Results SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO systimmune.com ↗
Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. |
| 2024-07-12 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M14D1（ADC）项目治疗晚期实体瘤获得I期临床试验批准通知书的公告 cninfo.com.cn ↗
公司自主研发的创新生物药 BL-M14D1（ADC）的药物临床试验获得批准。 |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | SystImmune Inc. | SystImmune Announces First Patient Dosed in Global Phase 3 Trial of BL-M14D1 in First-Line Extensive-Stage Small Cell Lung Cancer systimmune.com ↗ |
| 2026-06-15 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M14D1（DLL3 ADC）联合用药治疗广泛期小细胞肺癌获得药物临床试验批准通知书的公告 cninfo.com.cn ↗ |
| 2026-06-09 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于BL-M14D1（DLL3 ADC）联合免疫治疗用于一线广泛期小细胞肺癌患者的III期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2026-06-01 | SystImmune Inc. | SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO systimmune.com ↗ |
| 2024-07-12 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于注射用BL-M14D1（ADC）项目治疗晚期实体瘤获得I期临床试验批准通知书的公告 cninfo.com.cn ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BL-M14D1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06505824 ↗ |
| Route | Intravenous | “as intravenous infusion” NCT06505824 ↗ |