Pucotenlimab

Phase 2Monoclonal antibody

Pucotenlimab is one of 319 small molecule programs targeting Head and Neck Squamous Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

318

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Squamous Cell CarcinomaNot yet recruiting

Advanced Refractory Solid TumorsRecruiting

Penile CancerRecruiting

Gastric CancerNot yet recruiting

Hepatocellular CarcinomaRecruiting

Melanoma MetastaticRecruiting

Oral Squamous Cell CarcinomaNot yet recruiting

Squamous Cell CancerNot yet recruiting

Neoadjuvant TherapyNot yet recruiting

Locally-Advanced Rectal CancerRecruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Not yet recruiting

Advanced Refractory Solid TumorsPhase 2

Recruiting

Penile CancerPhase 2

Recruiting

Gastric CancerPhase 2

Not yet recruiting

Hepatocellular CarcinomaPreclinical

Recruiting

Melanoma MetastaticPhase 2

Recruiting

Oral Squamous Cell CarcinomaPhase 2

Not yet recruiting

Squamous Cell CancerPhase 2

Not yet recruiting

Neoadjuvant TherapyPhase 2

Not yet recruiting

Locally-Advanced Rectal CancerPhase 2

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Pucotenlimab

SSun Yat-sen University

Phase 2

1 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 5

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Sulfonylureas

Eli Lilly

Preclinical

1 10

Hyperpolarized 13c Pyruvate

UUniversity of Maryland, Baltimore

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Pancreatic Cancer

NCT07312422

Phase 1/2Recruiting

Effectiveness

NCT06456892

Q4 2027

Phase 2Not yet recruiting

Gastric Cancer

NCT07692334

Q2 2028

Phase 2Not yet recruiting

Total Neoadjuvant Therapy

NCT06872606

Q4 2028

Phase 2Not yet recruiting

Intrahepatic Cholangiocarcinoma

NCT07353827

Phase 2Not yet recruiting

Cutaneous Squamous Cell Carcinoma

NCT07394244

Clinical

Trials by Indication[1]

Penile Cancer2 trials

Pucotenlimab (HX008) Combined With Becotatug Vedotin (MRG003) as Neoadjuvant Therapy for Locally Advanced Penile Squamous Cell Carcinoma：A Multicenter, Single-Arm, Phase II Clinical Trial

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07767266·29 enrolled

Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial

Recruiting·JJiyan Liu·Phase 2·NCT07518979·60 enrolled

Pancreatic Cancer1 trial

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

Recruiting·ZZhejiang Provincial People's Hospital·Phase 1/2·NCT07312422·10 enrolled

Total Neoadjuvant Therapy1 trial

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 recruiting·SSir Run Run Shaw Hospital·Phase 2·NCT06872606·33 enrolled

Neoadjuvant Therapy1 trial

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

Not yet recruiting·SSir Run Run Shaw Hospital·Phase 2·NCT06895369·30 enrolled

Salivary Gland Cancer1 trial

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

Not yet recruiting·JJi Dongmei·Phase 2·NCT07464366·68 enrolled

12 more indications

Intrahepatic Cholangiocarcinoma1 trial

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

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07353827·36 enrolled

Squamous Cell Cancer1 trial

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

Not yet recruiting·GGroupe Oncologie Radiotherapie Tete et Cou·Phase 2·NCT06959108·106 enrolled

Cutaneous Squamous Cell Carcinoma1 trial

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma

Not yet recruiting·FFudan University·Phase 2·NCT07394244·38 enrolled

Locally-advanced Rectal Cancer1 trial

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

Recruiting·SSun Yat-sen University·Phase 2·NCT07448142·50 enrolled

Neoadjuvant Treatment1 trial

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

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT06770270·68 enrolled

Effectiveness1 trial

Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen

Recruiting·SSun Yat-sen University·Phase 1/2·NCT06456892·82 enrolled

Oral Squamous Cell Carcinoma1 trial

Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma：A Phase 2 Open-Label Clinical Trial

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07766889·32 enrolled

Melanoma Metastatic1 trial

Enhancing Immunogenicity in NRAS-Mutant Melanoma Via Autophagy Modulation: A Clinical and Mechanistic Study.

Recruiting·SSun Yat-sen University·Phase 2·NCT07750067·37 enrolled

Hepatocellular Carcinoma1 trial

An Open-Label, Multicenter, Phase I/II Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma

Recruiting·LLepu Biopharma Co., Ltd.·Preclinical·NCT07479485·160 enrolled

Advanced Refractory Solid Tumors1 trial

ELEVATE Study: A Phase II Single-Arm Open-Label Single-Center Exploratory Trial of Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Advanced Refractory Solid Tumors With EGFR-Positive

Recruiting·TTianjin Medical University Second Hospital·Phase 2·NCT07712029·32 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Prospective, Exploratory Clinical Study of Becotatug Vedotin Combined With Putlimab as Neoadjuvant Therapy Prior to Surgery and Adjuvant Radiotherapy After Surgery in Locally Advanced Head and Neck Squamous Cell Carcinoma

Not yet recruiting·JJiangsu Cancer Institute & Hospital·Phase 2·NCT07707167·35 enrolled

Gastric Cancer1 trial

A Single-Arm, Open-Label, Phase II Study of Becotatugvedotin Combined With Pucotenlimab in Patients With EGFR-Positive Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed Standard First-Line Therapy

Not yet recruiting·WWest China Second University Hospital·Phase 2·NCT07692334·28 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Pucotenlimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pucotenlimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pucotenlimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sun Yat-sen University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 2[1]
Company: SSun Yat-sen University

Pucotenlimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2028

Q4 2028

Trials by Indication[1]

Penile Cancer2 trials

Pancreatic Cancer1 trial

Total Neoadjuvant Therapy1 trial

Neoadjuvant Therapy1 trial

Salivary Gland Cancer1 trial

Intrahepatic Cholangiocarcinoma1 trial

Squamous Cell Cancer1 trial

Cutaneous Squamous Cell Carcinoma1 trial

Locally-advanced Rectal Cancer1 trial

Neoadjuvant Treatment1 trial

Effectiveness1 trial

Oral Squamous Cell Carcinoma1 trial

Melanoma Metastatic1 trial

Hepatocellular Carcinoma1 trial

Advanced Refractory Solid Tumors1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Gastric Cancer1 trial

References

Drug Info

Quick Facts

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