Pucotenlimab

Summary

Pucotenlimab (CHEMBL4650472) is a phase-3 clinical-stage antibody targeting PDCD1; indicated across 7 conditions including gastric neoplasm and hepatocellular carcinoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (PDCD1)
• Indications: 7 conditions
• Clinical trials: 35

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4650472
Name	Pucotenlimab
Type	Antibody
Max phase	3

Also known as: Hx 008, HX-008, Hx008, HX008, Pucotenlimab, PUCOTENLIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
PDCD1	programmed cell death 1 (CD279)	Binding	10.12	0%	Q15116

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): PDCD1.

Top Reactome pathways

3 total, by targets touching each:

Pathway	Targets	Genes
Co-inhibition by PD-1	1	PDCD1
Potential therapeutics for SARS	1	PDCD1
PD-L1(CD274) glycosylation and translocation to plasma membrane	1	PDCD1

Dominant GO biological processes

GO term	Targets
B cell apoptotic process	1
adaptive immune response	1
negative regulation of tolerance induction	1
negative regulation of T cell mediated immune response to tumor cell	1
negative regulation of B cell apoptotic process	1
apoptotic process	1
humoral immune response	1
negative regulation of inflammatory response	1
regulation of immune response	1
negative regulation of immune response	1
negative regulation of T cell receptor signaling pathway	1
negative regulation of T cell activation	1
positive regulation of T cell apoptotic process	1
regulatory T cell apoptotic process	1
immune system process	1

Indications & clinical

Indications

7 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
gastric neoplasm	3	MONDO:0021085	MONDO:0001056
hepatocellular carcinoma	2	MONDO:0007256	EFO:0000182
melanoma	2	MONDO:0005105	EFO:0000756
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
neoplasm	2	MONDO:0005070	EFO:0000616

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 35.

Phase distribution

Phase	Trials
PHASE2	19
PHASE1/PHASE2	6
PHASE3	4
PHASE1	3
PHASE2/PHASE3	2
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06976190	PHASE3	RECRUITING	A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT07524413	PHASE3	NOT_YET_RECRUITING	Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma
NCT07598318	PHASE2/PHASE3	NOT_YET_RECRUITING	Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations
NCT04486651	PHASE3	UNKNOWN	HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
NCT04750083	PHASE2/PHASE3	UNKNOWN	HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer
NCT05647954	PHASE3	UNKNOWN	A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver
NCT04616443	PHASE1/PHASE2	RECRUITING	OH2 Injection in Combination With HX008 for Melanoma.
NCT04868162	PHASE2	RECRUITING	A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
NCT06456892	PHASE1/PHASE2	RECRUITING	Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
NCT06524466	PHASE2	ACTIVE_NOT_RECRUITING	Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma
NCT06770270	PHASE2	RECRUITING	Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)
NCT06872606	PHASE2	NOT_YET_RECRUITING	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
NCT06895369	PHASE2	NOT_YET_RECRUITING	The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC
NCT06959108	PHASE2	RECRUITING	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
NCT07312422	PHASE1/PHASE2	RECRUITING	LDRT Combined With Pucotenlimab and Standard Therapy for Advanced Pancreatic Cancer: A Single-Arm Study
NCT07353827	PHASE2	NOT_YET_RECRUITING	FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma
NCT07381699	PHASE2	NOT_YET_RECRUITING	MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial
NCT07394244	PHASE2	NOT_YET_RECRUITING	Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma
NCT07448142	PHASE2	RECRUITING	Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer
NCT07464366	PHASE2	RECRUITING	The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study
NCT07518979	PHASE2	NOT_YET_RECRUITING	EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer
NCT07545083	PHASE2	NOT_YET_RECRUITING	Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC)
NCT07586124	PHASE2	NOT_YET_RECRUITING	Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
NCT07589049	PHASE2	NOT_YET_RECRUITING	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
NCT04574817	PHASE2	UNKNOWN	Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC)
NCT04738630	PHASE2	UNKNOWN	Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
NCT04741165	PHASE2	UNKNOWN	Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)
NCT04749485	PHASE2	UNKNOWN	A Study of HX008 for the Treatment of Patients With Malignant Melanoma
NCT04750382	PHASE1/PHASE2	UNKNOWN	A Study of HX008 for the Treatment of Patients With Metastatic Triple Negative Breast Cancer
NCT05338957	PHASE1/PHASE2	UNKNOWN	A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.
NCT05688605	PHASE1/PHASE2	UNKNOWN	A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors
NCT07054307	PHASE1	RECRUITING	MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma
NCT04756934	PHASE1	UNKNOWN	A Study of HX008 Plus LP002 for the Treatment of Patients With Advanced Melanoma
NCT04825392	PHASE1	UNKNOWN	A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors
NCT07188311	Not specified	RECRUITING	Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

4 molecules share ≥1 primary target. Top 4 by shared-target count:

Molecule	Source	Status	Shared targets
PYRVINIUM	ChEMBL	Phase 4 (approved)	PDCD1
RIFABUTIN	ChEMBL	Phase 4 (approved)	PDCD1
Gefitinib	PubChem	Approved	PDCD1
Pomalidomide	PubChem	Approved	PDCD1