Drugs / MRG004A
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04843709 | Jul 2021 → Mar 2024 | — | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07138846 | Jan → Jun 2027 expected | pancreatic neoplasm | Lepu Biopharma Co., Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-05-24 | Lepu Biopharma Co., Ltd. | Results 三项临床研究成果在2024年ASCO年会上公布 lepubiopharma.com ↗
在2.0mg/kg剂量组的12名既往已接受中位3线治疗的可评价PC患者中，有4例部分缓解（「PR」）及6例病情稳定（「SD」），因此客观缓解率（「ORR」）为33.3%（4/12），疾病控制率（「DCR」）为83.3%（10/ 12）。 |
| 2021-07-12 | Lepu Biopharma Co., Ltd. | Regulatory 拒绝同质化扎堆靶点，聚焦同类首创！一家潜力无穷的ADC国产龙头正冉冉升起！ lepubiopharma.com ↗
目前乐普生物的MRG004A今年二月份公司获得了美国FDA的临床批件，六月初药监局正式受理TF ADC的IND申请，未来公司预计将在TF阳性晚期实体瘤适应症领域（宫颈癌、卵巢癌、胰腺癌等）进行探索。 |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-05-24 | Lepu Biopharma Co., Ltd. | 三项临床研究成果在2024年ASCO年会上公布 lepubiopharma.com ↗ |
| 2023-12-14 | Lepu Biopharma Co., Ltd. | MRG004A 用于治疗胰腺癌 获FDA授予孤儿药资格认定 lepubiopharma.com ↗ |
| 2021-07-12 | Lepu Biopharma Co., Ltd. | 拒绝同质化扎堆靶点，聚焦同类首创！一家潜力无穷的ADC国产龙头正冉冉升起！ lepubiopharma.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MRG004A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07138846 ↗ |
| Route | Intravenous | “Administrated intravenously” NCT04843709 ↗ |