7 recruiting, 4 completed, 4 not yet recruiting, 1 active not recruiting. 14 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Recruiting 5, Not yet recruiting 4, Completed 3, Active not recruiting 1, Terminated 1 |
| Phase 1 | 2 | Completed 1, Recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow MRG003: new trials by email Literature Review of MRG003 trials Research Report on MRG003
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma Becotatug Vedotin (MRG003), Pucotenlimab - Oral Squamous Cell Carcinoma, Head and Neck Cancer | Phase 2 | Not yet recruiting | Sun Yat-sen University | 32 | 2026-09-01 | 2026-08-17 |
| Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive Becotatug Vedotin, Pucotenlimab - Advanced Refractory Solid Tumors, EGFR Gene Overexpression | Phase 2 | Recruiting | Tianjin Medical University Second Hospital | 32 | 2026-08-01 | 2026-07-17 |
| EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer Becotatug Vedotin, Pucotenlimab - Penile Cancer | Phase 2 | Recruiting | Jiyan Liu | 60 | 2026-07-22 | 2026-07-29 |
| Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II Becotatug Vedotin, Pucotenlimab - Biliary Tract Cancer (BTC), EGFR-positive Advanced Biliary Tract Carcinoma | Phase 2 | Not yet recruiting | HuiKai Li | 30 | 2026-07-01 | 2026-06-16 |
| MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC MRG003, Tislelizumab, Capecitabine - Nasopharyngeal Carcinoma, Local Recurrence | Phase 2 | Recruiting | Fujian Cancer Hospital | 25 | 2026-06-16 | 2026-10-19 |
| Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer Becotatug Vedotin, Cetuximab - RAS Wild Type mCRC | Phase 2 | Not yet recruiting | Fudan University | 31 | 2026-06-01 | 2026-03-24 |
| Becotatug Vedotin (MRG003) in Previously Treated Advanced Hepatocellular Carcinoma MRG003 - Hepato Cellular Carcinoma (HCC) | Phase 2 | Recruiting | Fudan University | 40 | 2026-04-17 | 2026-04-21 |
| MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma MRG003, HX008 - Penile Cancer | Phase 1 | Recruiting | Jiyan Liu | 10 | 2026-02-12 | 2026-04-07 |
| Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma Pucotenlimab, Becotatug Vedotin - Cutaneous Squamous Cell Carcinoma (CSCC) | Phase 2 | Not yet recruiting | Fudan University | 38 | 2026-01-09 | 2026-02-06 |
| Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck Pucotenlimab, MRG003 - Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 2 | Recruiting | Groupe Oncologie Radiotherapie Tete et Cou | 106 | 2025-10-13 | 2026-04-07 |
| A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma MRG003, Capecitabine tablets, Docetaxel injection - Recurrent or Metastatic Nasopharyngeal Carcinoma | Phase 2 | Active not recruiting | Lepu Biopharma Co., Ltd. | 238 | 2023-04-06 | 2026-08-31 |
| A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN MRG003, Cetuximab injection, Methotrexate Injection - Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Recruiting | Lepu Biopharma Co., Ltd. | 180 | 2023-04-04 | 2026-09-04 |
| A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer. MRG003 - Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Carcinoma | Phase 2 | Terminated | Lepu Biopharma Co., Ltd. | 6 | 2021-12-31 | 2026-09-09 |
| A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer MRG003 - Advanced or Metastatic Biliary Tract Cancer | Phase 2 | Completed | Lepu Biopharma Co., Ltd. | 15 | 2021-05-18 | 2026-09-09 |
| A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck MRG003, MRG003+HX008 - Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck | Phase 2 | Completed | Lepu Biopharma Co., Ltd. | 70 | 2021-04-23 | 2026-09-10 |
| A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer MRG003 - Carcinoma, Non-Small-Cell Lung | Phase 2 | Completed | Lepu Biopharma Co., Ltd. | 87 | 2021-04-16 | 2026-09-09 |
| A Study of MRG003 in Patients With Advanced Solid Tumors MRG003 - Advanced Solid Tumors | Phase 1 | Completed | Lepu Biopharma Co., Ltd. | 61 | 2018-05-09 | 2026-08-31 |
Squamous Cell Carcinoma of Head and Neck (3) · Biliary Tract Neoplasms (2) · Nasopharyngeal Carcinoma (2) · Penile Neoplasms (2) · Recurrence (2) · Carcinoma, Non-Small-Cell Lung (1) · Head and Neck Neoplasms (1) · Stomach Neoplasms (1)
Lepu Biopharma Co., Ltd. (7) · Fudan University (3) · Jiyan Liu (2) · Fujian Cancer Hospital (1) · Groupe Oncologie Radiotherapie Tete et Cou (1) · HuiKai Li (1) · Sun Yat-sen University (1) · Tianjin Medical University Second Hospital (1)
China (14) · France (1)
Aiping Zhou, Doctor (1) · Aiping Zhou, MD (1) · Haitao Wang, Ph.D. (1) · Ruihua Xu, Doctor (1) · Ruihua Xu, M.D. (1) · Ye Guo, Doctor (1) · Ye Guo, PhD (1) · Yuankai Shi, Doctor (1)
PMID 35511148, PMID 41720100, PMID 42757773
2023 (1)