14 not yet recruiting, 11 recruiting. 24 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 24 | Not yet recruiting 13, Recruiting 11 |
| Phase 1 | 3 | Recruiting 3 |
| Phase 3 | 2 | Not yet recruiting 2 |
Follow Pucotenlimab: new trials by email Literature Review of Pucotenlimab trials Research Report on Pucotenlimab
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 |
|---|---|---|---|---|---|---|
| ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC/OPSCC Becotatug Vedotin (MRG003), Pucotenlimab, Cisplatin - Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Phase 2 | Not yet recruiting | Huashan Hospital | 40 | 2026-10-20 | 2026-09-28 |
| Becotatug Vedotin Plus Pucotenlimab for Metastatic Colorectal Cancer Becotatug Vedotin (MRG003), Pucotenlimab - Metastatic Colorectal Cancer | Phase 2 | Recruiting | Fudan University | 31 | 2026-10-15 | 2026-10-20 |
| 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 |
| A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma Pucotenlimab, Becotatug vedotin, Radiotherapy - LA HNSCC | Phase 2 | Not yet recruiting | Jiangsu Cancer Institute & Hospital | 35 | 2026-08-31 | 2026-07-16 |
| 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 |
| Becotatugvedotin Plus Pucotenlimab in EGFR-Positive Advanced Gastric/GEJ Adenocarcinoma Becotatug Vedotin (MRG003), Pucotenlimab - Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma | Phase 2 | Not yet recruiting | West China Second University Hospital | 28 | 2026-07-20 | 2026-07-09 |
| Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer Pucotenlimab, Becotatug vedotin, Radiotherapy - NSCLC (Advanced Non-small Cell Lung Cancer) | Phase 2 | Not yet recruiting | Anhui Provincial Cancer Hospital | 39 | 2026-07-15 | 2026-06-04 |
| 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 |
| Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations Becotatug Vedotin, Pucotenlimab, Gemcitabine - Cholangiocarcinoma | Phase 2 / Phase 3 | Not yet recruiting | Sir Run Run Shaw Hospital | 164 | 2026-05-20 | 2026-05-20 |
| Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study Becotatug Vedotin, Pucotenlimab - Head and Neck Squamous Cell Carcinoma | Phase 2 | Not yet recruiting | Sun Yat-sen University | 42 | 2026-05-01 | 2026-05-15 |
| MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) MRG006A, Pucotenlimab, Bevacizumab - Hepatocellular Carcinoma | Phase 1 / Phase 2 | Recruiting | Lepu Biopharma Co., Ltd. | 160 | 2026-04-08 | 2026-07-28 |
| Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma Becotatug Vedotin, Pucotenlimab, Gemcitabine + cisplatin (GP) - Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer | Phase 3 | Not yet recruiting | Sun Yat-sen University | 514 | 2026-04-01 | 2026-04-13 |
| Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma Tunlametinib, Pucotenlimab, Hydroxychloroquine (HC) - Melanoma Metastatic, NRAS Mutation | Phase 2 | Recruiting | Sun Yat-sen University | 37 | 2026-04-01 | 2026-08-10 |
| The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study MRG 003, Pucotenlimab - Salivary Gland Carcinomas | Phase 2 | Recruiting | Ji Dongmei | 90 | 2026-03-19 | 2026-04-01 |
| Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer Low-dose radiotherapy, Pucotenlimab, CAPEOX/XELOX - Colorectal Cancer (CRC) | Phase 2 | Recruiting | Sun Yat-sen University | 50 | 2026-03-15 | 2026-10-15 |
| FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma hepatic arterial infusion chemotherapy (HAIC), Donafenib, Pucotenlimab - Intrahepatic Cholangiocarcinoma (Icc), Hepatic Arterial Infusion Chemotherapy | Phase 2 | Not yet recruiting | Sun Yat-sen University | 36 | 2026-02-01 | 2026-01-20 |
| 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 |
| A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Drug Combination Therapy - Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma | Phase 2 | Not yet recruiting | Sun Yat-sen University | 30 | 2026-01-01 | 2026-01-21 |
| 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 |
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Squamous Cell Carcinoma of Head and Neck (5) · Cholangiocarcinoma (2) · Colorectal Neoplasms (2) · Head and Neck Neoplasms (2) · Rectal Neoplasms (2) · Adenocarcinoma (1) · Biliary Tract Neoplasms (1) · Carcinoma (1) · Carcinoma, Hepatocellular (1) · Carcinoma, Non-Small-Cell Lung (1) · Cirrhosis, Familial, with Pulmonary Hypertension (1) · Melanoma (1) · Nasopharyngeal Neoplasms (1) · Neoplasms (1) · Pancreatic Neoplasms (1)
Sun Yat-sen University (8) · Sir Run Run Shaw Hospital (3) · Fudan University (2) · Anhui Provincial Cancer Hospital (1) · Groupe Oncologie Radiotherapie Tete et Cou (1) · Huashan Hospital (1) · HuiKai Li (1) · Ji Dongmei (1) · Jiangsu Cancer Institute & Hospital (1) · Jiyan Liu (1) · Lepu Biopharma Co., Ltd. (1) · Second Affiliated Hospital, Zhejiang University, School of Medicine (1) · Tianjin Medical University Second Hospital (1) · West China Second University Hospital (1) · Zhejiang Provincial People's Hospital (1)
China (19) · France (1)
Chunyan Chen, MD, PhD (1) · Haitao Wang, Ph.D. (1) · Lai-ping Zhong (1) · Li Shen, M.D. (1) · Pei-Rong Ding (1) · Xiaohua Jiang, Master (1) · Xuekui Liu, MD, PhD (1)
2023 (1)