Drugs / BL-M17D1
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06714617 | Apr 2025 → Sep 2027 expected | HER2 positive breast carcinoma, endometrium neoplasm, fallopian tube cancer, female breast carcinoma +6 | SystImmune Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06503783 | Aug 2024 → Aug 2026 overdue | breast cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06500052 | Jul 2024 → Aug 2026 overdue | colorectal cancer, esophageal cancer, gastric cancer, malignant pancreatic neoplasm | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-11-08 | 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-M17D1（ADC）用于治疗晚期实体瘤患者的I期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2024-11-07 | SystImmune Inc. | Regulatory SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors systimmune.com ↗
SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology. |
| 2024-06-22 | 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-M17D1（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-M17D1（ADC）的药物临床试验获得批准。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-08 | 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-M17D1（ADC）用于治疗晚期实体瘤患者的I期临床试验申请获得FDA许可的公告 cninfo.com.cn ↗ |
| 2024-11-07 | SystImmune Inc. | SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors systimmune.com ↗ |
| 2024-06-22 | 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-M17D1（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. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BL-M17D1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06714617 ↗ |
| Route | Intravenous | “Administration by intravenous infusion for a cycle of 3 weeks.” NCT06500052 ↗ |