Pucotenlimab

DRUG19 trials

Sponsors

Sun Yat-sen University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, Groupe Oncologie Radiotherapie Tete et Cou, Zhejiang Provincial People's Hospital

Conditions

Advanced Refractory Solid TumorsBecotatug VedotinBiliary Tract Cancer (BTC)CholangiocarcinomaColorectal Cancer (CRC)Cutaneous Squamous Cell Carcinoma (CSCC)EGFR Gene OverexpressionEGFR-positive Advanced Biliary Tract Carcinoma

Phase 1

Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen

RecruitingNCT06456892

Sun Yat-sen UniversityPediatric Cancer, Rhabdomyosarcoma

Start: 2024-06-06End: 2026-12-06Target: 82Updated: 2024-06-13

LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study

RecruitingNCT07312422

Zhejiang Provincial People's HospitalLDRT, Pancreatic Cancer, PD-1 Inhibitor +2

Start: 2025-09-30End: 2026-10-30Target: 10Updated: 2026-01-26

Phase 2

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

RecruitingNCT06770270

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRectal Cancer

Start: 2024-08-01End: 2030-06-30Target: 68Updated: 2025-09-04

Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer

Not yet recruitingNCT06872606

Sir Run Run Shaw HospitalRectal Adenocarcinoma

Start: 2025-04-01End: 2028-04-01Target: 33Updated: 2025-03-12

The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC

Not yet recruitingNCT06895369

Sir Run Run Shaw HospitalSquamous Cell Carcinoma of Head and Neck

Start: 2025-05-01End: 2033-12-31Target: 30Updated: 2025-03-26

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

RecruitingNCT06959108

Groupe Oncologie Radiotherapie Tete et CouLocally Advanced Head and Neck Squamous Cell Carcinoma

Start: 2025-10-13End: 2029-10-01Target: 106Updated: 2026-04-07

FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Not yet recruitingNCT07353827

Sun Yat-sen UniversityHepatic Arterial Infusion Chemotherapy, Intrahepatic Cholangiocarcinoma (Icc)

Start: 2026-02-01End: 2028-12-31Target: 36Updated: 2026-01-20

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma

Not yet recruitingNCT07394244

Fudan UniversityCutaneous Squamous Cell Carcinoma (CSCC)

Start: 2026-01-09End: 2028-12-31Target: 38Updated: 2026-02-06

Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer

RecruitingNCT07448142

Sun Yat-sen UniversityColorectal Cancer (CRC)

Start: 2026-03-15End: 2032-09-01Target: 50Updated: 2026-05-07

The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study

RecruitingNCT07464366

Ji DongmeiSalivary Gland Carcinomas

Start: 2026-03-19End: 2029-09-30Target: 90Updated: 2026-04-01

EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer

Not yet recruitingNCT07518979

Jiyan LiuPenile Cancer

Start: 2026-07-30End: 2031-05-01Target: 60Updated: 2026-07-01

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

Not yet recruitingNCT07589049

Sun Yat-sen UniversityHead and Neck Squamous Cell Carcinoma

Start: 2026-05-01End: 2029-05-01Target: 42Updated: 2026-05-15

Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations

Not yet recruitingNCT07598318

Sir Run Run Shaw HospitalCholangiocarcinoma

Start: 2026-05-20End: 2028-12-31Target: 164Updated: 2026-05-20

Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer

Not yet recruitingNCT07627321

Anhui Provincial Cancer HospitalNSCLC (Advanced Non-small Cell Lung Cancer)

Start: 2026-07-15End: 2029-07-16Target: 39Updated: 2026-06-04

Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II

Not yet recruitingNCT07649980

HuiKai LiBiliary Tract Cancer (BTC), EGFR-positive Advanced Biliary Tract Carcinoma

Start: 2026-07-01End: 2029-12-31Target: 30Updated: 2026-06-16

Becotatugvedotin Plus Pucotenlimab in EGFR-Positive Advanced Gastric/GEJ Adenocarcinoma

Not yet recruitingNCT07692334

West China Second University HospitalBecotatug Vedotin, Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma +1

Start: 2026-07-20End: 2027-12-31Target: 28Updated: 2026-07-09

A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Not yet recruitingNCT07707167

Jiangsu Cancer Institute & HospitalLA HNSCC

Start: 2026-08-31End: 2029-01-31Target: 35Updated: 2026-07-16

Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive

RecruitingNCT07712029

Tianjin Medical University Second HospitalAdvanced Refractory Solid Tumors, EGFR Gene Overexpression

Start: 2026-08-01End: 2028-12-31Target: 32Updated: 2026-07-17

Phase 3

Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma

Not yet recruitingNCT07524413

Sun Yat-sen UniversityNasopharyngeal Cancer, Nasopharyngeal Cancinoma (NPC)

Start: 2026-04-01End: 2032-04-01Target: 514Updated: 2026-04-13

Related Papers

Pucotenlimab plus dose-intensified radiotherapy and chemotherapy for locally advanced rectal cancer: Preliminary results from a prospective, single-arm phase II trial (PUCRT).

Journal of Clinical Oncology2026-05-28

Abstract CT180: 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

Cancer Research2026-04-17

Safety and efficacy of pucotenlimab combined with standard chemotherapy regimens in the neoadjuvant treatment of pediatric patients with intermediate or high-risk rhabdomyosarcoma: A phase I/II study.

Journal of Clinical Oncology2025-05-28