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Drugs / TRASTUZUMAB VEDOTIN
last change Oct 2025 re-read 8 days ago

TRASTUZUMAB VEDOTIN

also known as MRG002 · Trastuzumab vedotina · Trastuzumab vedotine · Trastuzumab--vcmmae conjugate
Developed for
breast cancer · gastroesophageal cancer · biliary tract cancer · cancer · cancer of unknown primary site · gastric cancer · neoplasm · non-small cell lung carcinoma
+1 more · urothelial carcinoma
Investigated by
Shanghai Miracogen Inc. · Zhiguo Luo, MD, PhD

Trials 11

today NCT06869174 · Ph 2 NCT05338957 · Ph 1/2 NCT05263869 · Ph 2 NCT05141747 · Ph 2 NCT05141786 · Ph 2 NCT04924699 · Ph 2/3 NCT04837508 · Ph 2 NCT04492488 · Ph 1/2 NCT04742153 · Ph 2 NCT04839510 · Ph 2 NCT04941339 · Ph 1
201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04941339 Nov 2018 → Oct 2022 neoplasm Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05338957 Aug 2022 → Jun 2024 cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 1/2 NCT04492488 May 2021 → Oct 2022 overdue gastroesophageal cancer Shanghai Miracogen Inc. Active not recruiting No outcome recorded
Phase 27 trials
Phase 2 NCT06869174 Mar 2025 → Mar 2027 expected cancer of unknown primary site Zhiguo Luo, MD, PhD Not yet recruiting No outcome recorded
Phase 2 NCT05263869 Mar → Dec 2022 breast cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2 NCT05141747 Jan 2022 → Dec 2023 gastric cancer, gastroesophageal cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2 NCT05141786 Dec 2021 → Dec 2023 non-small cell lung carcinoma Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2 NCT04837508 Jun 2021 → Dec 2022 biliary tract cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2 NCT04742153 May 2021 → Feb 2023 breast cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2 NCT04839510 Apr 2021 → Jun 2022 urothelial carcinoma Shanghai Miracogen Inc. Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04924699 Jun 2021 → Sep 2023 breast cancer Shanghai Miracogen Inc. Unknown No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT05754853 Comparator Apr 2023 → Oct 2025 overdue urothelial carcinoma Shanghai Miracogen Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2024-12-15 Lepu Biopharma Co., Ltd. Results SABCS 2024丨乐普生物MRG002-009 II期临床研究结果大公布，HER2+ mBC肝转移迎来转机 lepubiopharma.com ↗
IRC基于RECIST v1.1评估的ORR为60.8%（95%CI：50.6-70.3），疾病控制率（DCR）86.3%（95%CI：78.0-92.3）。
2022-06-07 Lepu Biopharma Co., Ltd. Results 【2022ASCO专家点评】周爱萍教授：大放异彩，MRG002单药治疗化疗/PD-1失败的晚期或转移性UC患者ORR高达63% lepubiopharma.com ↗
既往经过含铂化疗和PD-(L)1治疗失败的患者亚组中，CR率为10%，ORR为63%，该亚组人群中的中位PFS为6.4个月（图3）。
2021-09-29 Lepu Biopharma Co., Ltd. Results CSCO2021丨江泽飞教授：原创引领抗HER2未来，新型ADC药物MRG002 Ⅱ期研究崭露头角 lepubiopharma.com ↗
在疗效方面，可评估的18例患者中，5例首次疗效评估已达到PR。
2021-09-26 Lepu Biopharma Co., Ltd. Results CSCO2021丨李进教授：HER2阳性实体瘤新希望，新型ADC药物MRG002 Ⅰ期研究公布 lepubiopharma.com ↗
在Ia 22例可评估实体瘤患者中，既往接受HER2靶向治疗患者比例为88%，既往中位治疗线数为5线，整体ORR 为45%，DCR为82%，中位PFS 7.4个月。
2021-09-14 Lepu Biopharma Co., Ltd. Results 双星闪耀ESMO，乐普生物奏华章 lepubiopharma.com ↗
结论：这项I期临床研究显示了MRG003在多线治疗后晚期实体瘤（包括NPC和SCCHN）患者中可控的安全性和令人鼓舞的抗肿瘤活性。
2021-07-19 Lepu Biopharma Co., Ltd. Results 经TDM1治疗六线进展乳腺癌患者经MRG002治疗快速PR，MRG002为HER2阳性乳腺癌患者带来新希望 lepubiopharma.com ↗
吉林大学第一医院吕铮副主任医师、贾琳主治医师收治的一例多线治疗后进展的HER2阳性晚期乳腺癌患者，经MRG002治疗仅2周期，肝转移灶从由15.97 mm缩小至10.01 mm，评估为部分缓解（PR）。
2021-07-12 Lepu Biopharma Co., Ltd. Results 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 ↗
最新的临床数据显示，MRG002安全性良好，客观缓解率（ORR）高达50.0%，疾病控制率（DCR）高达81.3%，初步的疗效数据展现出了不输于国际上大部分表现优异的ADC药物的潜力。

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as TRASTUZUMAB VEDOTIN ChEMBL registry synonym — accepted as the source's own label CHEMBL5315030 ↗
Known as MRG002 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04492488 ↗
11

NCT05263869 ↗

NCT06869174 ↗

NCT04742153 ↗

NCT04837508 ↗

NCT05338957 ↗

NCT04924699 ↗

NCT05754853 ↗

NCT04839510 ↗

NCT04941339 ↗

NCT05141747 ↗

Show 1 more source
Known as Trastuzumab vedotina ChEMBL registry synonym — accepted as the source's own label CHEMBL5315030 ↗
Known as Trastuzumab vedotine ChEMBL registry synonym — accepted as the source's own label CHEMBL5315030 ↗
Known as Trastuzumab--vcmmae conjugate ChEMBL registry synonym — accepted as the source's own label CHEMBL5315030 ↗
Route Intravenous “Administrated intravenously” NCT04492488 ↗