Drugs / IMM27M
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06764836 | Jul 2024 → Jan 2026 overdue | hepatocellular carcinoma | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05235438 | Jun 2022 → Aug 2023 | autoimmune lymphoproliferative syndrome due to CTLA4 haploinsufficiency | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07687914 | Jul 2026 → Jul 2027 expected | hepatocellular carcinoma | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-05-15 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科泰泽苏拜单抗(IMM27M)联合奥希替尼针对EGFR突变的局部晚期或转移性非鳞非小细胞肺癌的临床试验申请获得NMPA批准 immuneonco.com ↗
泰泽苏拜单抗(tazlestobart,IMM27M)联合奥希替尼针对EGFR突变的局部晚期或转移性非鳞非小细胞肺癌的 Ib/II期临床试验申请，已正式获得国家药品监督管理局(NMPA)批准。 |
| 2023-10-27 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科IMM2510联合IMM27M治疗晚期实体瘤的I期临床试验申请获得国家药品监督管理局 (NMPA) 批准 immuneonco.com ↗ |
| 2023-09-11 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Results 宜明昂科IMM27M完成I期剂量爬坡患者入组并确定了II期推荐剂量 immuneonco.com ↗
日前经过安全审核委员会（SRC）讨论一致同意5mg/kg Q3W作为单药的RP2D剂量进入II期进一步开发。 |
| 2023-08-18 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科IMM27M联合IMM2510的临床研究申请获得国家药品监督管理局(NMPA)受理 immuneonco.com ↗
2023年8月18日，宜明昂科生物医药技术(上海)股份有限公司（以下简称“宜明昂科”）宣布，公司自主研发的ADCC加强型CTLA-4抗体药物 (项目编号:IMM27M），联合同时靶向PD-L1和VEGF的双特异性抗体-受体重组蛋白药物（项目编号: IMM2510）的临床研究申请 (IND) 获得国家药品监督管理局 (NMPA) 受理。 |
| 2023-03-15 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科IMM27M联合PD-1抗体在晚期实体瘤患者中的Ib/II期临床研究获得国家药品监督管理局 (NMPA)许可 immuneonco.com ↗
非常高兴我们的新一代CTLA-4抗体项目IMM27M联合替雷利珠单抗在晚期实体瘤患者中的Ib/II期临床获得NMPA许可。 |
| 2021-11-04 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科ADCC加强型CTLA-4抗体项目获得NMPA临床试验研究许可 immuneonco.com ↗
2021年11月4日，宜明昂科生物医药技术（上海）有限公司宣布，公司自主研发的ADCC加强型CTLA-4抗体药物 (项目编号:IMM27M）获得NMPA临床试验研究许可。 |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMM27M | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05235438 ↗ |
| Action | Inhibit | “Anti-CTLA-4 Humanized monoclonal antibody” NCT07687914 ↗ |
| Modality | Monoclonal antibody | “IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody)” NCT06764836 ↗ |
| Route | Intravenous | “Intravenous injection” NCT06764836 ↗ |