Puyouheng (pucotenlimab) / Taizhou Hanzhong Biopharma, Lepu Med, HanX Biopharma - LARVOL DELTA

A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Fudan University

IO biomarker • New P2 trial • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • EGFR

Safety and efficacy of pucotenlimab combined with standard chemotherapy regimens in the preoperative treatment of pediatric patients with intermediate or high-risk rhabdomyosarcoma: A phase I/II study (AACR 2026) - "Abstract is embargoed at this time."

Clinical • P1/2 data • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Updated long term efficacy results of phase II study for becotatug vedotin combined with pucotenlimab in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO 2025) - "It may provide an efficacious treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. The efficacy and safety of MRG003 combined with HX008 in NPC is currently undergoing further investigation in randomized controlled clinical trials."

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov) - P1/2 | N=160 | Not yet recruiting | Sponsor: Lepu Biopharma Co., Ltd.

Checkpoint inhibition • New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

TSEMPRMSGC: The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: Ji Dongmei

IO biomarker • New P2 trial • Oncology • Salivary Gland Cancer

Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • pMMR • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Pucotenlimab Combined with Lenvatinib and eribulin in Patients with Advanced Sarcoma Failed in First-Line Therapy, a Single-Arm, Open-Label, Multicenter, Phase II Clinical Study (ChiCTR) - P2 | N=33 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New P2 trial • Oncology • Sarcoma • Solid Tumor

Clinical Efficacy of Pucotenlimab Combined with Lenvatinib and SOX Versus SOX Alone in Patients with HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Center Randomized Controlled Trial (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: Department of Gastric Surgery, Fujian Medical University Union Hospital; Fujian Medical University Union Hospital

New trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

FUGES032: Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1 | N=100 | Enrolling by invitation | Sponsor: Fujian Medical University

New P1 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

Pucotenlimab Combined with Lenvatinib and eribulin in Patients with Advanced Melanoma Failed in First-Line Therapy, a Single-Arm, Open-Label, Multicenter, Phase II Clinical Study (ChiCTR) - P=N/A | N=35 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Melanoma • Oncology • Solid Tumor

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

PIONEER-HN: 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 (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pucotenlimab Combined with Concurrent Chemoradiotherapy as Neoadjuvant Therapy for Microsatellite Stable (MSS) Locally Advanced Rectal Cancer (ChiCTR) - P2 | N=140 | Not yet recruiting | Sponsor: Fuzhou University Affiliated Provincial Hospital; Fuzhou University Affiliated Provincial Hospital

New P2 trial • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Zhejiang Provincial People's Hospital | Phase classification: P=N/A ➔ P1/2 | N=20 ➔ 10

Enrollment change • Phase classification • Oncology • Pancreatic Cancer • Solid Tumor

Magic-C002: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=446 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Oncology • Solid Tumor

A Prospective, Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Pucotenlimab, Lenvatinib, and Temozolomide for Resectable Head and Neck Mucosal Melanoma (PLT-NAT-HNMM-II) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

New P2 trial • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • PD-L1

LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Zhejiang Provincial People's Hospital

New trial • Oncology • Pancreatic Cancer • Solid Tumor

A case of Vogt-Koyanagi-Harada syndrome-like lesions during pucotenlimab treatment for malignant melanoma (PubMed, Zhonghua Yan Ke Za Zhi) - "A patient presented to the ophthalmology department with bilateral blurred vision, with a history of intravenous infusion of Pucotenlimab injection for malignant melanoma. Based on the medical history, the patient was diagnosed with bilateral drug-related Vogt-Koyanagi-Harada (VKH) syndrome-like lesions. Treatment with intravitreal injection of dexamethasone sustained-release implant in the right eye combined with systemic glucocorticoid therapy resulted in improvement of ocular symptoms."

Journal • Macular Edema • Melanoma • Oncology • Ophthalmology • Solid Tumor

MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Multicenter, Single-Arm, Open-Label Clinical Study of Cetuximab Beta in Combination with Pucotenlimab and Chemotherapy as Neoadjuvant Therapy for KRAS/NRAS Wild-Type Left-Sided Colon Cancer and Upper Rectal Cance (ChiCTR) - P2 | N=53 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Fujian Medical University; The First Affiliated Hospital of Fujian Medical University

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • KRAS