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Priya Life Science Compound trial record
Compound · clinical trials

Pucotenlimab clinical trials

Also listed in trial records as HX008
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 36 trials in our China, Japan and France registers that name Pucotenlimab as an intervention. Synced 9 Nov 2026
36Current trials
22Recruiting now
18Lead sponsors
3Country registers
At a glance

Pucotenlimab is named as an intervention in 36 current clinical trials in our China, Japan and France registers. 22 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sun Yat-sen University (10). The most-studied condition is Penile Cancer.

How Pucotenlimab works

All drug targets →
  • Programmed cell death protein 1 inhibitor Inhibitor
    Target: PDCD1 programmed cell death 1
    ✓ In ChEMBL and the Guide to Pharmacology
Diseases it has been tested for in clinical trials, by furthest phase
  • Colorectal cancerPhase 3
  • Gastric adenocarcinomaPhase 3
  • Gastroesophageal junction adenocarcinomaPhase 3
  • MelanomaPhase 3
  • Nasopharyngeal carcinomaPhase 3
  • Rectal cancerPhase 3
  • Biliary tract cancerPhase 2/3
  • Non-small cell lung carcinomaPhase 2/3
  • Acral lentiginous melanomaPhase 2
  • Breast cancerPhase 2
32 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650472, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13886, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Pucotenlimab

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting2261%
  • Not yet open1233%
  • Active, closed13%
  • By invitation13%

Trials by phase

  • Phase 22672%
  • Phase 1/2617%
  • Phase 326%
  • Early Phase 113%
  • Phase 113%
01

Clinical trials of Pucotenlimab

36 trials
StudyPhaseStatusLead sponsorRegisters
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT06976190 · ClinicalTrials.gov ↗ · Recurrent or Metastatic Nasopharyngeal Carcinoma
Phase 3 Recruiting Lepu Biopharma Co., Ltd China
Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma
NCT06192797 · ClinicalTrials.gov ↗ · Cholangiocarcinoma Non-resectable
Phase 2 Recruiting Tongji Hospital China
Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)
NCT06770270 · ClinicalTrials.gov ↗ · Rectal Cancer
Phase 2 Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine China
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
NCT06959108 · ClinicalTrials.gov ↗ · Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase 2 Recruiting Groupe Oncologie Radiotherapie Tete et Cou France
Safety and Efficacy of Pucotenlimab in pLECC
NCT06969534 · ClinicalTrials.gov ↗ · Lymphoepithelioma-like Carcinoma, Lymphoepithelioma, Carcinoma
Phase 2 Recruiting Sun Yat-sen University China
MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
NCT07235566 · ClinicalTrials.gov ↗ · Thyroid Cancer
Phase 2 Recruiting Fudan University China
Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
NCT07448142 · ClinicalTrials.gov ↗ · Colorectal Cancer (CRC)
Phase 2 Recruiting Sun Yat-sen University China
The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study
NCT07464366 · ClinicalTrials.gov ↗ · Salivary Gland Carcinomas
Phase 2 Recruiting Ji Dongmei China
A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer
NCT07497919 · ClinicalTrials.gov ↗ · Penile Cancer
Phase 2 Recruiting Fudan University China
EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer
NCT07518979 · ClinicalTrials.gov ↗ · Penile Cancer
Phase 2 Recruiting Jiyan Liu China
Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
NCT07586124 · ClinicalTrials.gov ↗ · Head and Neck Squamous Cell Carcinoma
Phase 2 Recruiting Lepu Biopharma Co., Ltd China
Becotatug Vedotin Combined With Pucotenlimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma
NCT07632339 · ClinicalTrials.gov ↗ · Head and Neck Cancer
Phase 2 Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University China
Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive
NCT07712029 · ClinicalTrials.gov ↗ · Advanced Refractory Solid Tumors, EGFR Gene Overexpression
Phase 2 Recruiting Tianjin Medical University Second Hospital China
Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant Melanoma
NCT07750067 · ClinicalTrials.gov ↗ · Melanoma Metastatic, NRAS Mutation
Phase 2 Recruiting Sun Yat-sen University China
Becotatug Vedotin Plus Pucotenlimab for Metastatic Colorectal Cancer
NCT07884188 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer
Phase 2 Recruiting Fudan University China
OH2 Oncolytic Viral Therapy in Solid Tumors
NCT03866525 · ClinicalTrials.gov ↗ · Solid Tumor, Gastrointestinal Cancer
Phase 1/2 Recruiting Binhui Biopharmaceutical Co., Ltd China
OH2 Injection in Combination With HX008 for Melanoma.
NCT04616443 · ClinicalTrials.gov ↗ · Melanoma
Phase 1/2 Recruiting Binhui Biopharmaceutical Co., Ltd China
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors
NCT05688605 · ClinicalTrials.gov ↗ · Advanced Solid Tumors
Phase 1/2 Recruiting Lepu Biopharma Co., Ltd China
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
NCT06456892 · ClinicalTrials.gov ↗ · Rhabdomyosarcoma, Pediatric Cancer
Phase 1/2 Recruiting Sun Yat-sen University China
LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
NCT07312422 · ClinicalTrials.gov ↗ · Pancreatic Cancer, PD-L1, PD-1 Inhibitor
Phase 1/2 Recruiting Zhejiang Provincial People's Hospital China
MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)
NCT07479485 · ClinicalTrials.gov ↗ · Hepatocellular Carcinoma
Phase 1/2 Recruiting Lepu Biopharma Co., Ltd China
MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma
NCT07054307 · ClinicalTrials.gov ↗ · Penile Cancer
Phase 1 Recruiting Jiyan Liu China
Pucotenlimab Combined with MRG002 for HER2-positive Cancer of Unknown Primary
NCT06869174 · ClinicalTrials.gov ↗ · Cancer of Unknown Primary
Phase 2 Not yet open Zhiguo Luo, MD, PhD China
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
NCT06872606 · ClinicalTrials.gov ↗ · Rectal Adenocarcinoma
Phase 2 Not yet open Sir Run Run Shaw Hospital China
The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC
NCT06895369 · ClinicalTrials.gov ↗ · Squamous Cell Carcinoma of Head and Neck
Phase 2 Not yet open Sir Run Run Shaw Hospital China
FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma
NCT07353827 · ClinicalTrials.gov ↗ · Intrahepatic Cholangiocarcinoma (Icc), Hepatic Arterial Infusion Chemotherapy
Phase 2 Not yet open Sun Yat-sen University China
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
NCT07354984 · ClinicalTrials.gov ↗ · Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Phase 2 Not yet open Sun Yat-sen University China
Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma
NCT07394244 · Cutaneous Squamous Cell Carcinoma (CSCC)
Phase 2 Not yet open Fudan University China
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
NCT07589049 · ClinicalTrials.gov ↗ · Head and Neck Squamous Cell Carcinoma
Phase 2 Not yet open Sun Yat-sen University China
Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer
NCT07627321 · ClinicalTrials.gov ↗ · NSCLC (Advanced Non-small Cell Lung Cancer)
Phase 2 Not yet open Anhui Provincial Cancer Hospital China
A Prospective, Exploratory Study of Becotatug Vedotin Plus Putlimab for Neoadjuvant Therapy and Adjuvant Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT07707167 · ClinicalTrials.gov ↗ · LA HNSCC
Phase 2 Not yet open Jiangsu Cancer Institute & Hospital China
Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma
NCT07766889 · ClinicalTrials.gov ↗ · Oral Squamous Cell Carcinoma, Head and Neck Cancer, Locally Advanced Head and Neck Cancer
Phase 2 Not yet open Sun Yat-sen University China
Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer
NCT07767266 · ClinicalTrials.gov ↗ · Penile Cancer, Penile Squamous Cell Carcinoma (PSCC)
Phase 2 Not yet open Sun Yat-sen University China
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
NCT07915258 · ClinicalTrials.gov ↗ · Squamous Cell Carcinoma of Head and Neck (SCCHN)
Phase 2 Not yet open Sun Yat-sen University China
Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07356466 · ClinicalTrials.gov ↗ · Gastric (Stomach) Cancer
Early Phase 1 By invitation Fujian Medical University China
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer
NCT05652894 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer
Phase 3 Active, closed Taizhou Hanzhong biomedical co. LTD China, Japan

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Pucotenlimab

44 conditions
Penile Cancer4Metastatic Colorectal Cancer2Head and Neck Cancer2Head and Neck Squamous Cell Carcinoma2Rhabdomyosarcoma1Pediatric Cancer1Recurrent or Metastatic Nasopharyngeal Carcinoma1Cancer of Unknown Primary1Salivary Gland Carcinomas1Rectal Cancer1Melanoma Metastatic1NRAS Mutation1
All 44 conditions
Condition (as registered)Trials
Penile Cancer4
Metastatic Colorectal Cancer2
Head and Neck Cancer2
Head and Neck Squamous Cell Carcinoma2
Rhabdomyosarcoma1
Pediatric Cancer1
Recurrent or Metastatic Nasopharyngeal Carcinoma1
Cancer of Unknown Primary1
Salivary Gland Carcinomas1
Rectal Cancer1
Melanoma Metastatic1
NRAS Mutation1
Cutaneous Squamous Cell Carcinoma (CSCC)1
Advanced Refractory Solid Tumors1
EGFR Gene Overexpression1
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma1
Lymphoepithelioma-like Carcinoma1
Lymphoepithelioma1
Carcinoma1
Squamous Cell Carcinoma of Head and Neck1
Squamous Cell Carcinoma of Head and Neck (SCCHN)1
NSCLC (Advanced Non-small Cell Lung Cancer)1
Pancreatic Cancer1
PD-L11
PD-1 Inhibitor1
LDRT1
Thyroid Cancer1
Colorectal Cancer (CRC)1
Gastric (Stomach) Cancer1
Rectal Adenocarcinoma1
LA HNSCC1
Oral Squamous Cell Carcinoma1
Locally Advanced Head and Neck Cancer1
Neoadjuvant Therapy1
Hepatocellular Carcinoma1
Intrahepatic Cholangiocarcinoma (Icc)1
Hepatic Arterial Infusion Chemotherapy1
Cholangiocarcinoma Non-resectable1
Penile Squamous Cell Carcinoma (PSCC)1
Locally Advanced Head and Neck Squamous Cell Carcinoma1
Solid Tumor1
Gastrointestinal Cancer1
Advanced Solid Tumors1
Melanoma1
05

Related compounds

06

Questions about Pucotenlimab trials

How many clinical trials are testing Pucotenlimab?

36 current trials in our China, Japan and France registers name Pucotenlimab (also registered as HX008) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Pucotenlimab trials recruiting patients?

Yes. 22 of the 36 trials are recruiting: 21 with sites in China and 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Pucotenlimab clinical trials?

Sun Yat-sen University (10), Lepu Biopharma Co., Ltd (4), Fudan University (4) and Sir Run Run Shaw Hospital (2), among 18 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pucotenlimab works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pucotenlimab works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pucotenlimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.