Tislelizumab

Summary

Tislelizumab (CHEMBL4297840) is an approved antibody (ATC L01FF09) targeting PDCD1; indicated across 69 conditions including neoplasm and non-small cell lung carcinoma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FF09
• Targets: 1 (PDCD1)
• Indications: 69 conditions
• Clinical trials: 478

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297840
Name	Tislelizumab
Type	Antibody
Max phase	4
ATC	L01FF09

Also known as: Bgb-a317, BGB-A317, BGBA-317, BGBA317, BGN-1, BGN1, JHL-2108, JHL2108, Tevimbra, Tislelizumab, Tislelizumab-jsgr, Tizveni

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	9.82	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

69 indications (10 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
neoplasm	4	MONDO:0005070	EFO:0000616
non-small cell lung carcinoma	4	MONDO:0005233	EFO:0003060
esophageal squamous cell carcinoma	4	MONDO:0005580	EFO:0005922
gastric neoplasm	4	MONDO:0021085	MONDO:0001056
gastric adenocarcinoma	4	MONDO:0005036	EFO:0000503
adenocarcinoma	4	MONDO:0004970	EFO:0000228
hepatocellular carcinoma	3	MONDO:0007256	EFO:0000182
small cell lung carcinoma	3	MONDO:0008433	EFO:0000702
urothelial carcinoma	3	MONDO:0040679	EFO:0008528
Hodgkins lymphoma	3	MONDO:0004952	MONDO:0009348
diffuse large B-cell lymphoma	3	MONDO:0018905	EFO:0000403
breast neoplasm	3	MONDO:0021100	MONDO:0007254
intrahepatic cholangiocarcinoma	3	MONDO:0003210	EFO:1001961
urinary bladder neoplasm	3	MONDO:0004987	EFO:0000294
rectal cancer	3	MONDO:0006519	EFO:1000657
oral cavity squamous cell carcinoma	3	MONDO:0004958	EFO:0000199
cholangiocarcinoma	3	MONDO:0019087	EFO:0005221
nasopharyngeal carcinoma	3	MONDO:0015459	MONDO:0015459
rectal neoplasm	3	MONDO:0002165	MONDO:0044937
lymphoma	2	MONDO:0005062	EFO:0000574
lung neoplasm	2	MONDO:0021117	MONDO:0008903
triple-negative breast carcinoma	2	MONDO:0005494	EFO:0005537
non-Hodgkin lymphoma	2	MONDO:0018908	EFO:0005952
head and neck cancer	2	MONDO:0005627	EFO:0006859
ovarian cancer	2	MONDO:0008170	MONDO:0008170
melanoma	2	MONDO:0005105	EFO:0000756
exocrine pancreatic carcinoma	2	MONDO:0005192	EFO:0002618
nasopharyngeal neoplasm	2	MONDO:0005375	EFO:0004252
head and neck squamous cell carcinoma	2	MONDO:0010150	EFO:0000181
carcinoma	2	MONDO:0004993	EFO:0000313
glioblastoma	2	MONDO:0018177	EFO:0000519
squamous cell carcinoma	2	MONDO:0005096	EFO:0000707
squamous cell lung carcinoma	2	MONDO:0005097	EFO:0000708
biliary tract neoplasm	2	MONDO:0005304	EFO:0003891
colorectal neoplasm	2	MONDO:0005335	EFO:0004142
colorectal carcinoma	2	MONDO:0024331	EFO:1001951
kidney cancer	2	MONDO:0002367	MONDO:0002367
nasal cavity and paranasal sinus lethal midline granuloma	2	MONDO:0006828	MONDO:0019472
colonic neoplasm	2	MONDO:0005401	MONDO:0021063
astrocytoma (excluding glioblastoma)	2	MONDO:0019781	EFO:0000272
colorectal adenocarcinoma	2	MONDO:0005008	EFO:0000365
oligodendroglioma	2	MONDO:0016695	EFO:0000632
renal cell carcinoma	2	MONDO:0005086	EFO:0000681
cervical adenocarcinoma	2	MONDO:0005153	EFO:0001416
pancreatic neoplasm	2	MONDO:0021040	EFO:0003860
metastatic prostate carcinoma	2	MONDO:0004956	EFO:0000196
clear cell renal carcinoma	2	MONDO:0005005	EFO:0000349
lung adenocarcinoma	2	MONDO:0005061	EFO:0000571
leukemia	1	MONDO:0005059	EFO:0000565
endometrium neoplasm	1	MONDO:0021251	MONDO:0011962
T-cell non-Hodgkin lymphoma	1	MONDO:0015760	MONDO:0015760
peripheral T-cell lymphoma, not otherwise specified	1	MONDO:0004964	EFO:0000211
digestive system neoplasm	1	MONDO:0021223	EFO:0008549
pancreatic ductal adenocarcinoma	1	MONDO:0005184	MONDO:0005184

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

Clinical trials

Total trials: 478.

Phase distribution

Phase	Trials
PHASE2	284
PHASE1	56
PHASE3	52
PHASE1/PHASE2	46
Not specified	23
PHASE4	7
PHASE2/PHASE3	6
EARLY_PHASE1	4

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06356675	PHASE4	NOT_YET_RECRUITING	A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy
NCT06761911	PHASE4	NOT_YET_RECRUITING	BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma
NCT06951841	PHASE4	NOT_YET_RECRUITING	Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum and Immune Checkpoint Inhibitors Combined With Anlotinib for the Maintenance of Extensive Small Cell Lung Cancer After First-line Induction
NCT07320105	PHASE4	RECRUITING	Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)
NCT07485920	PHASE4	NOT_YET_RECRUITING	A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer
NCT05603065	PHASE4	UNKNOWN	Tislelizumab With Chemotherapy or Radiation for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma (TINES)
NCT06357598	PHASE4	UNKNOWN	Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer
NCT03967977	PHASE3	ACTIVE_NOT_RECRUITING	Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
NCT04164199	PHASE3	ACTIVE_NOT_RECRUITING	Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies
NCT04170283	PHASE3	ACTIVE_NOT_RECRUITING	Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
NCT04379635	PHASE3	ACTIVE_NOT_RECRUITING	Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
NCT04973306	PHASE2/PHASE3	RECRUITING	Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC
NCT05152147	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
NCT05211232	PHASE3	ACTIVE_NOT_RECRUITING	Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma
NCT05699655	PHASE2/PHASE3	RECRUITING	Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 Vs Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer
NCT05840016	PHASE3	ACTIVE_NOT_RECRUITING	AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
NCT05919030	PHASE3	RECRUITING	A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
NCT05990127	PHASE3	NOT_YET_RECRUITING	A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
NCT06017583	PHASE3	RECRUITING	Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
NCT06206733	PHASE3	ACTIVE_NOT_RECRUITING	ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
NCT06258811	PHASE3	RECRUITING	Neoadjuvant Immunochemotherapy for LAOSCC
NCT06312982	PHASE2/PHASE3	RECRUITING	A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
NCT06332274	PHASE3	RECRUITING	tislelizUMaB in canceR Patients With molEcuLar residuaL Disease
NCT06364904	PHASE3	NOT_YET_RECRUITING	A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.
NCT06416410	PHASE3	RECRUITING	JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation
NCT06465446	PHASE3	NOT_YET_RECRUITING	A Study of IMM01 Plus Tiselizumab Versus Physician’s Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma
NCT06520683	PHASE3	RECRUITING	Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer
NCT06563245	PHASE2/PHASE3	RECRUITING	Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
NCT06598527	PHASE3	RECRUITING	Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study
NCT06704620	PHASE3	NOT_YET_RECRUITING	Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer
NCT06745908	PHASE3	RECRUITING	Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
NCT06793917	PHASE3	RECRUITING	Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
NCT06914011	PHASE3	NOT_YET_RECRUITING	Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma
NCT06939439	PHASE3	ACTIVE_NOT_RECRUITING	Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer
NCT06944496	PHASE3	NOT_YET_RECRUITING	A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07043400	PHASE3	RECRUITING	A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07068516	PHASE3	NOT_YET_RECRUITING	Perioperative Tislelizumab Plus Chemotherapy Versus Chemotherapy Alone in MHC-II-Positive Gastric/GEJ Cancer
NCT07131319	PHASE2/PHASE3	RECRUITING	SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC
NCT07132008	PHASE3	NOT_YET_RECRUITING	Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer
NCT07315750	PHASE3	RECRUITING	A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

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