Spartalizumab

Summary

Spartalizumab (CHEMBL4297831) is a phase-3 clinical-stage antibody targeting PDCD1; indicated across 20 conditions including melanoma and cutaneous melanoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (PDCD1)
• Indications: 20 conditions
• Clinical trials: 60

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297831
Name	Spartalizumab
Type	Antibody
Max phase	3

Also known as: ANTI-PD1 MONOCLONAL ANTIBODY PDR001, Espartalizumab, NVP-LZV184, PDR-001, Pdr001, PDR001, Spartalizumab, SPARTALIZUMAB

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	9.7	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

20 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
melanoma	3	MONDO:0005105	EFO:0000756
cutaneous melanoma	3	MONDO:0005012	EFO:0000389
exocrine pancreatic carcinoma	3	MONDO:0005192	EFO:0002618
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
triple-negative breast carcinoma	2	MONDO:0005494	EFO:0005537
esophageal squamous cell carcinoma	2	MONDO:0005580	EFO:0005922
gastric neoplasm	2	MONDO:0021085	MONDO:0001056
neuroendocrine carcinoma	2	MONDO:0002120	MONDO:0002120
lung neoplasm	2	MONDO:0021117	MONDO:0008903
nasopharyngeal carcinoma	2	MONDO:0015459	MONDO:0015459
hepatocellular carcinoma	1	MONDO:0007256	EFO:0000182
lymphoma	1	MONDO:0005062	EFO:0000574
neoplasm	1	MONDO:0005070	EFO:0000616
renal cell carcinoma	1	MONDO:0005086	EFO:0000681
plasma cell myeloma	1	MONDO:0009693	EFO:0001378
head and neck squamous cell carcinoma	1	MONDO:0010150	EFO:0000181
breast neoplasm	1	MONDO:0021100	MONDO:0007254
gastrointestinal stromal tumor	1	MONDO:0011719	MONDO:0011719
pancreatic ductal adenocarcinoma	1	MONDO:0005184	MONDO:0005184

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

Clinical trials

Total trials: 60.

Phase distribution

Phase	Trials
PHASE1	31
PHASE2	17
PHASE1/PHASE2	9
EARLY_PHASE1	2
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02967692	PHASE3	TERMINATED	A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
NCT04544111	PHASE2	ACTIVE_NOT_RECRUITING	PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer
NCT04802876	PHASE2	ACTIVE_NOT_RECRUITING	Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
NCT05201066	PHASE2	ACTIVE_NOT_RECRUITING	Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
NCT02325739	PHASE1/PHASE2	COMPLETED	FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
NCT02404441	PHASE1/PHASE2	COMPLETED	Phase I/II Study of PDR001 in Patients With Advanced Malignancies
NCT02460224	PHASE1/PHASE2	COMPLETED	Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
NCT02605967	PHASE2	COMPLETED	Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT02608268	PHASE1/PHASE2	TERMINATED	Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
NCT02795429	PHASE1/PHASE2	COMPLETED	Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC
NCT02807844	PHASE1/PHASE2	COMPLETED	Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
NCT02829723	PHASE1/PHASE2	TERMINATED	A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors
NCT02955069	PHASE2	COMPLETED	Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
NCT03207867	PHASE2	TERMINATED	A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma
NCT03365791	PHASE2	COMPLETED	PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
NCT03484923	PHASE2	COMPLETED	Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma
NCT03499899	PHASE2	COMPLETED	A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer
NCT03609424	PHASE1/PHASE2	COMPLETED	PDR001 Plus Imatinib for Metastatic or Unresectable GIST
NCT03647488	PHASE2	COMPLETED	Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
NCT03668431	PHASE2	UNKNOWN	Dabrafenib + Trametinib + PDR001 In Colorectal Cancer
NCT03693326	PHASE2	UNKNOWN	PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities
NCT03785496	PHASE2	UNKNOWN	Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus
NCT04191421	PHASE1/PHASE2	COMPLETED	Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
NCT04310397	PHASE2	TERMINATED	Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
NCT04323436	PHASE2	TERMINATED	Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations
NCT04390763	PHASE2	TERMINATED	Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
NCT05135845	PHASE2	SUSPENDED	Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma
NCT03891953	PHASE1	ACTIVE_NOT_RECRUITING	Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
NCT04058756	PHASE1	ACTIVE_NOT_RECRUITING	Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments
NCT07157345	PHASE1	RECRUITING	Testing if PDR-001 Can Safely and Effectively Remove Harmful Brain Protein in Parkinson’s Disease
NCT01351103	PHASE1	COMPLETED	A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands
NCT02403193	PHASE1	COMPLETED	Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
NCT02452268	PHASE1	TERMINATED	A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers
NCT02607813	PHASE1	TERMINATED	Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations
NCT02678260	PHASE1	COMPLETED	Phase I Study of PDR001 in Patients With Advanced Malignancies.
NCT02740270	PHASE1	COMPLETED	Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas
NCT02890069	PHASE1	COMPLETED	A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat
NCT02900664	PHASE1	COMPLETED	A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
NCT02936102	PHASE1	TERMINATED	A Study of FAZ053 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
NCT02947165	PHASE1	COMPLETED	Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

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