Drugs / Becotatug Vedotin
Becotatug Vedotin
also known as
MRG003 · Anti-egfr adc mrg003 · Becotatug vedotina · Becotatug vedotine · Vebecototagene Autoteucovaline
Other / unclassified targets EGFR
Trials 61 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07697040 | Jul 2026 → Jul 2029 expected | esophageal squamous cell carcinoma | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07584499 | May 2026 → May 2027 expected | Wilms tumor, atypical teratoid rhabdoid tumor, diffuse intrinsic pontine glioma, head and neck squamous cell carcinoma +5 | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 1 | NCT07054307 | Feb → Jul 2026 overdue | penile cancer | Jiyan Liu | Recruiting | No outcome recorded |
| Phase 1 | NCT04868344 | May 2018 → Mar 2021 | cancer | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07685470 | Jun 2026 → May 2028 expected | pancreatic ductal adenocarcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07542717 | Apr 2026 → Mar 2028 expected | — | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05688605 | Jun 2022 → Aug 2027 expected | cancer | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 246 trials · 1 met primary | ||||||
| Phase 2 | NCT07844551 | Oct 2026 → Oct 2028 expected | oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07800000 | Sep 2026 → Sep 2028 expected | anal canal squamous cell carcinoma | Wang Xin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07825753 | Sep 2026 → Sep 2027 expected | breast cancer, pancreatic adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07303283 | Sep 2026 → Aug 2030 expected | nasopharyngeal carcinoma | Kai Hu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07497919 | Sep 2026 → May 2029 expected | penile cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07707167 | Aug 2026 → Jan 2028 expected | head and neck squamous cell carcinoma | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07712029 | Aug 2026 → Aug 2028 expected | refractory malignant neoplasm | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07686926 | Aug 2026 → Jul 2028 expected | esophageal squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07518979 | Jul 2026 → May 2028 expected | penile cancer | Jiyan Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07692334 | Jul 2026 → Sep 2027 expected | gastric cancer, gastroesophageal junction adenocarcinoma | West China Second University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07381075 | Jul 2026 → Dec 2028 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07627321 | Jul 2026 → Jul 2028 expected | non-small cell lung carcinoma | Anhui Provincial Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07586124 | Jul 2026 → Dec 2027 expected | head and neck squamous cell carcinoma | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07683507 | Jul 2026 → Dec 2027 expected | head and neck squamous cell carcinoma | Feng Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07649980 | Jul 2026 → Jul 2029 expected | biliary tract cancer | HuiKai Li | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07665190 | Jul 2026 → Oct 2027 expected | hypopharynx squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07677475 | Jun 2026 → Jan 2029 expected | head and neck squamous cell carcinoma | Dongguan People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07632339 | Jun 2026 → Jun 2028 expected | head and neck cancer | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT07424664 | Jun 2026 → Mar 2027 expected | cervical cancer, vaginal neoplasm, vulva cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT07490119 | Jun 2026 → Jun 2028 expected | colorectal cancer, susceptibility to, 4 | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07267338 | Jun 2026 → Dec 2027 expected | nasopharyngeal carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07628855 | May 2026 → Aug 2028 expected | hereditary nonpolyposis colon cancer | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07579598 | May → Dec 2026 expected | salivary gland adenoid cystic carcinoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07522879 | May 2026 → Oct 2028 expected | adenoid cystic carcinoma, nasal cavity and paranasal sinus carcinoma | Eye & ENT Hospital of Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07589049 | May 2026 → Nov 2027 expected | head and neck squamous cell carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07555860 | Apr 2026 → Dec 2027 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07536789 | Apr 2026 → Apr 2028 expected | hepatocellular carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07814287 | Apr → Dec 2026 expected | head and neck squamous cell carcinoma | Xuekui Liu | Recruiting | No outcome recorded |
| Phase 2 | NCT07531979 | Apr 2026 → Mar 2027 expected | esophageal squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07545083 | Apr 2026 → Mar 2027 expected | head and neck squamous cell carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07464366 | Mar 2026 → May 2028 expected | salivary gland carcinoma | Ji Dongmei | Recruiting | No outcome recorded |
| Phase 2 | NCT07514533 | Mar 2026 → Dec 2027 expected | cholangiocarcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07496190 | Feb 2026 → Feb 2032 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07381699 | Feb 2026 → Feb 2028 expected | nasopharyngeal carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07393477 | Feb 2026 → Jul 2028 expected | head and neck squamous cell carcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07394244 | Jan 2026 → Dec 2028 expected | skin squamous cell carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07331428 | Jan 2026 → Dec 2027 expected | nasopharyngeal carcinoma | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06959108 | Oct 2025 → Jun 2029 expected | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Recruiting | No outcome recorded |
| Phase 2 | NCT07235566 | Apr 2025 → Apr 2029 expected | thyroid cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06530914 | Aug 2024 → Dec 2026 expected | head and neck squamous cell carcinoma | Lei Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06509997 | Aug 2024 → Dec 2026 expected | head and neck squamous cell carcinoma | Lei Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05126719 | Apr 2023 → Dec 2024 overdue | nasopharyngeal carcinoma | Lepu Biopharma Co., Ltd. | Active not recruiting | Met primary |
| Phase 2 | NCT05188209 | Dec 2021 → Oct 2022 | gastroesophageal cancer | Lepu Biopharma Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04838964 | May 2021 → Oct 2022 | biliary tract cancer | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04868162 | Apr 2021 → Jul 2024 | head and neck squamous cell carcinoma | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04838548 | Apr 2021 → Mar 2023 | non-small cell lung carcinoma | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07598318 | May 2026 → Dec 2027 expected | cholangiocarcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07705243 | Jul 2026 → Jul 2028 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT07524413 | Apr 2026 → Apr 2030 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07459296 | Mar 2026 → Apr 2030 expected | nasopharyngeal carcinoma | First Affiliated Hospital of Guangxi Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT07524452 | Feb 2026 → Feb 2031 expected | head and neck squamous cell carcinoma | Ming-Yuan Chen | Recruiting | No outcome recorded |
| Phase 3 | NCT07481799 | Feb 2026 → Feb 2029 expected | metastatic malignant neoplasm | Ming-Yuan Chen | Recruiting | No outcome recorded |
| Phase 3 | NCT06976190 | May 2025 → May 2029 expected | nasopharyngeal carcinoma | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05751512 | Apr 2023 → Dec 2027 expected | head and neck squamous cell carcinoma | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-03-23 | Lepu Biopharma Co., Ltd. | Regulatory 乐普生物MRG003联合普特利单抗头颈鳞癌围手术期IND获批，全球首创实现治疗线数全面前移 lepubiopharma.com ↗
用于局部晚期可切除头颈部鳞状细胞癌围手术期治疗的临床试验申请，已获国家药品监督管理局临床试验默示许可。 |
| 2025-10-22 | Lepu Biopharma Co., Ltd. | Results ESMO 2025｜乐普生物“三箭齐发”，瞄准ADC+IO黄金赛道 lepubiopharma.com ↗
具体数据显示，ORR和DCR分别达到73.3%和93.3%，中位PFS为10.9个月。 |
| 2025-06-09 | Lepu Biopharma Co., Ltd. | Results 2025ASCO丨徐瑞华教授、韩非教授：ORR近三倍提升！Becotatug Vedotin开启复发/转移性鼻咽癌后线治疗新征程 lepubiopharma.com ↗
截至2024年6月30日，Becotatug Vedotin组经BICR评估的ORR为30.2%，化疗组ORR为11.5%，数值近三倍提升，中位PFS获益翻倍，显著降低疾病进展或死亡风险37%（5.82个月vs. 2.83个月；HR=0.63，P=0.0146）。 |
| 2024-12-08 | Lepu Biopharma Co., Ltd. | Results 【4134】ESMO ASIA 2024丨徐瑞华教授团队：MRG003与普特利单抗联用，解围R/M-NPC困境 lepubiopharma.com ↗
本次ESMO ASIA会议上报道的II期研究中R/M-NPC队列的初步结果，进一步佐证了PD-1联合MRG003治疗R/M-NPC患者的疗效，为免疫治疗失败的患者提供了一种新的治疗选择[6]。 |
| 2022-11-14 | Lepu Biopharma Co., Ltd. | Results CSCO 2022丨徐瑞华教授团队：突破性疗法！EGFR靶向ADC MRG003治疗晚期鼻咽癌Ⅱ期研究公布 lepubiopharma.com ↗
亚组分析显示， 96.5%的受试者EGFR表达量为1+及以上，无论肿瘤组织EGFR表达量高低，MRG003均取得了良好的疗效。 |
| 2021-09-17 | Lepu Biopharma Co., Ltd. | Results 徐瑞华教授：MRG003荣登2021ESMO，有望成为首个EGFR靶向ADC，造福晚期实体瘤患者 lepubiopharma.com ↗
2021年欧洲肿瘤内科学会（ESMO大会）公布的初步结果显示，总体客观缓解率（ORR）为30%，疾病控制率（DCR）为63%，其中头颈部鳞癌（SCCHN）、鼻咽癌（NPC）患者的ORR分别为40%和44%，DCR分别高达80%和78%。 |
| 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1b期临床试验显示，MRG003治疗头颈癌的总缓解率（ORR）达到40%，疾病控制率（DCR）达到80%。 |
| 2021-06-25 | Lepu Biopharma Co., Ltd. | Results EGFR下一站：双抗与ADC lepubiopharma.com ↗
1b期临床试验中，HNSCC的总缓解率ORR达到40.0%，疾病控制率DCR达到80.0%。 |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | becotatug vedotin | “We evaluated the efficacy and safety of MRG003 (becotatug vedotin), an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC), in previously treated R/M NPC.” PMID 41720100 ↗ Feb 202644“Becotatug Vedotin Plus Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy-Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal” NCT07800000 ↗ “Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC)” NCT07545083 ↗ “MRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]” NCT07542717 ↗ “Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma” NCT07536789 ↗ “1. Becotatugvedotin: 2mg/kg, intravenous, every 3 weeks, on day 1” NCT07514533 ↗ “MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab” NCT07677475 ↗ |
| Known as | Anti-egfr adc mrg003 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068210 ↗ |
| Known as | Becotatug vedotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068210 ↗ |
| Known as | Becotatug vedotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068210 ↗ |
| Known as | MRG003 | “To evaluate the efficacy and safety of Becotatug Vedotin (EGFR-targeted ADC, MRG003) plus Pucotenlimab (PD-1 inhibitor), compared with platinum-based...” NCT07844551 ↗32“Becotatug vedotin (MRG003) is an antibody-drug conjugate (ADC) consisting of a humanized anti-EGFR IgG1 monoclonal antibody covalently linked to the microtubule-disrupting...” NCT07825753 ↗ “MRG003 is administered intravenously at 2.3 mg/kg on day 1 of each cycle, every three weeks, as monotherapy, for up to two years or until treatment discontinuation criteria are met.” NCT07464366 ↗ “Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) conjugated with monomethyl auristatin E (MMAE).” NCT07692334 ↗ “Neoadjuvant Phase: All subjects will receive 2 cycles of Becotatug vedotin (MRG003): 2.0 mg/kg, Q3W, D1, IV(60 ± 15 min, first cycle infusion ≥ 60 min).” NCT07707167 ↗ “Becotatug vedotin (MRG003) is an antibody-drug conjugate that carries the payload monomethyl auristatin E (MMAE), a microtubule inhibitor.” NCT07481799 ↗ “Becotatug vedotin (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR).” NCT07522879 ↗ “Becotatug Vedotin (MRG003): The initial dosage is 2.3 mg/kg, administered intravenously every three weeks per treatment cycle.” NCT07579598 ↗ “Becotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1.” NCT07627321 ↗ “MRG003 [Becotatug vedotin, an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC)]” NCT07542717 ↗ “Participants receive Becotatug vedotin (MRG003) in combination with Cisplatin and concurrent radiotherapy.” NCT07697040 ↗ |
| Known as | Vebecototagene Autoteucovaline | “MRG003 (Vebecototagene Autoteucovaline), an anti-EGFR antibody-drug conjugate” NCT07677475 ↗ |
| Action | Deplete | “thereby inducing targeted cell death” NCT07424664 ↗ |
| Modality | Monoclonal antibody | “The antibody drug conjugate drug MRG003 comprises an anti-epidermal growth factor receptor (EGFR) humanized immunoglobulin G1 monoclonal antibody that is conjugated with...” PMID 35511148 ↗ Jul 2022 |
| Route | Intravenous | “Administered intravenously” NCT04838548 ↗ |
| Target | EGFR | “The antibody drug conjugate drug MRG003 comprises an anti-epidermal growth factor receptor (EGFR) humanized immunoglobulin G1 monoclonal antibody” PMID 35511148 ↗ Jul 2022 |