Sintilimab

drug
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Also known as ANTI-PD-1 MONOCLONAL ANTIBODY IBI308IBI-308Ibi308Tyvyt

Summary

Sintilimab (CHEMBL4297829) is a phase-3 clinical-stage antibody targeting PDCD1; indicated across 64 conditions including hepatocellular carcinoma and non-small cell lung carcinoma.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Antibody
  • Targets: 1 (PDCD1)
  • Indications: 64 conditions
  • Clinical trials: 394

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL4297829
NameSintilimab
TypeAntibody
Max phase3

Also known as: ANTI-PD-1 MONOCLONAL ANTIBODY IBI308, IBI-308, Ibi308, IBI308, Sintilimab, Tyvyt, SINTILIMAB

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).

GeneTargetActionpAffinityCancer dependencyUniProt
PDCD1programmed cell death 1 (CD279)Binding9.60%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:

PathwayTargetsGenes
Co-inhibition by PD-11PDCD1
Potential therapeutics for SARS1PDCD1
PD-L1(CD274) glycosylation and translocation to plasma membrane1PDCD1

Dominant GO biological processes

GO termTargets
B cell apoptotic process1
adaptive immune response1
negative regulation of tolerance induction1
negative regulation of T cell mediated immune response to tumor cell1
negative regulation of B cell apoptotic process1
apoptotic process1
humoral immune response1
negative regulation of inflammatory response1
regulation of immune response1
negative regulation of immune response1
negative regulation of T cell receptor signaling pathway1
negative regulation of T cell activation1
positive regulation of T cell apoptotic process1
regulatory T cell apoptotic process1
immune system process1

Indications & clinical

Indications

64 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).

IndicationTrial phaseMONDOEFO
hepatocellular carcinoma3MONDO:0007256EFO:0000182
non-small cell lung carcinoma3MONDO:0005233EFO:0003060
nasopharyngeal neoplasm3MONDO:0005375EFO:0004252
esophageal squamous cell carcinoma3MONDO:0005580EFO:0005922
colorectal adenocarcinoma3MONDO:0005008EFO:0000365
colorectal carcinoma3MONDO:0024331EFO:1001951
gastric neoplasm3MONDO:0021085MONDO:0001056
lung neoplasm3MONDO:0021117MONDO:0008903
Hodgkins lymphoma3MONDO:0004952MONDO:0009348
gastric adenocarcinoma3MONDO:0005036EFO:0000503
breast neoplasm3MONDO:0021100MONDO:0007254
carcinoma of esophagus3MONDO:0019086EFO:0002916
colorectal neoplasm3MONDO:0005335EFO:0004142
gastric carcinoma3MONDO:0004950EFO:0000178
lymphoma2MONDO:0005062EFO:0000574
neoplasm2MONDO:0005070EFO:0000616
small cell lung carcinoma2MONDO:0008433EFO:0000702
diffuse large B-cell lymphoma2MONDO:0018905EFO:0000403
renal cell carcinoma2MONDO:0005086EFO:0000681
sarcoma2MONDO:0005089EFO:0000691
squamous cell carcinoma2MONDO:0005096EFO:0000707
cervical adenocarcinoma2MONDO:0005153EFO:0001416
primary cutaneous T-cell non-Hodgkin lymphoma2MONDO:0000607EFO:0002913
oral cavity cancer2MONDO:0005515EFO:0005570
ovarian cancer2MONDO:0008170MONDO:0008170
nasal cavity and paranasal sinus lethal midline granuloma2MONDO:0006828MONDO:0019472
oral cavity squamous cell carcinoma2MONDO:0004958EFO:0000199
peripheral T-cell lymphoma, not otherwise specified2MONDO:0004964EFO:0000211
clear cell adenocarcinoma2MONDO:0005004EFO:0000348
neuroblastoma2MONDO:0005072EFO:0000621
rectal cancer2MONDO:0006519EFO:1000657
intrahepatic cholangiocarcinoma2MONDO:0003210EFO:1001961
soft tissue sarcoma2MONDO:0018078EFO:1001968
head and neck squamous cell carcinoma2MONDO:0010150EFO:0000181
angioimmunoblastic T-cell lymphoma2MONDO:0004977EFO:0000255
clear cell renal carcinoma2MONDO:0005005EFO:0000349
endometrium neoplasm2MONDO:0021251MONDO:0011962
mesothelioma2MONDO:0005065EFO:0000588
exocrine pancreatic carcinoma2MONDO:0005192EFO:0002618
pancreatic neoplasm2MONDO:0021040EFO:0003860
angiosarcoma2MONDO:0016982EFO:0003968
cholangiocarcinoma2MONDO:0019087EFO:0005221
neuroendocrine neoplasm2MONDO:0019496EFO:1001901
undifferentiated pleomorphic sarcoma2MONDO:0002142EFO:1001972
neuroendocrine carcinoma2MONDO:0002120MONDO:0002120
salivary gland cancer2MONDO:0004669MONDO:0004669
glioblastoma2MONDO:0018177EFO:0000519
malignant pancreatic neoplasm2MONDO:0009831EFO:1000359
gallbladder neoplasm2MONDO:0021253MONDO:0005411
squamous cell lung carcinoma2MONDO:0005097EFO:0000708
cervical carcinoma2MONDO:0005131EFO:0001061
adenocarcinoma2MONDO:0004970MONDO:0003219
nasopharyngeal carcinoma2MONDO:0015459MONDO:0015459
carcinoma1MONDO:0004993EFO:0000313

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

Clinical trials

Total trials: 394.

Phase distribution

PhaseTrials
PHASE2252
PHASE139
PHASE336
PHASE1/PHASE227
Not specified26
PHASE2/PHASE38
PHASE43
EARLY_PHASE13

Top trials by phase / activity

NCTPhaseStatusTitle
NCT05843292PHASE4NOT_YET_RECRUITINGShort-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer
NCT06761911PHASE4NOT_YET_RECRUITINGBV in the Treatment of Relapsed/refractory Hodgkin Lymphoma
NCT07010393PHASE4NOT_YET_RECRUITINGGenotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study
NCT05116462PHASE3ACTIVE_NOT_RECRUITINGNeoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer
NCT05171660PHASE3ACTIVE_NOT_RECRUITINGCombination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer
NCT05236972PHASE3RECRUITINGPACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
NCT05244798PHASE3NOT_YET_RECRUITINGSintilimab Plus NCT or NCRT Versus NCRT for ESCC
NCT05357846PHASE3RECRUITINGPD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
NCT05429463PHASE3RECRUITINGNeoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ)
NCT05484024PHASE2/PHASE3NOT_YET_RECRUITINGShort-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer
NCT05495152PHASE3RECRUITINGAdjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT05522231PHASE2/PHASE3ACTIVE_NOT_RECRUITINGEfficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
NCT05549037PHASE3RECRUITINGEffect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC
NCT05593458PHASE3RECRUITINGTransarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
NCT05890742PHASE3ACTIVE_NOT_RECRUITINGA Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
NCT05918094PHASE3RECRUITINGComparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma
NCT05976568PHASE2/PHASE3NOT_YET_RECRUITINGA Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT06089369PHASE3NOT_YET_RECRUITINGPostoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
NCT06089382PHASE3NOT_YET_RECRUITINGA Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
NCT06497985PHASE3RECRUITINGA Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
NCT06584032PHASE3RECRUITINGStudy of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
NCT06618664PHASE3RECRUITINGA Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
NCT06900218PHASE3NOT_YET_RECRUITINGPD-1 Antibody Sintilimab Combined With Capecitabine as Adjuvant Therapy for High-Risk Nasopharyngeal Carcinoma
NCT07186621PHASE3RECRUITINGAdjuvant Radiotherapy of Sintilimab Versus TACE for HCC
NCT07306663PHASE3ACTIVE_NOT_RECRUITINGSintilimab Combined With Chemotherapy Induction Therapy Followed by CCRT vs. CCRT for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study
NCT07459296PHASE3RECRUITINGBecotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
NCT07490262PHASE2/PHASE3RECRUITINGA Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.
NCT07537946PHASE3NOT_YET_RECRUITINGLocal Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
NCT03150875PHASE3COMPLETEDA Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC
NCT03607539PHASE3COMPLETEDEfficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
NCT03629925PHASE3COMPLETEDSintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC
NCT03700476PHASE3UNKNOWNSintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma
NCT03745170PHASE3COMPLETEDEfficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
NCT03748134PHASE3COMPLETEDSintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
NCT03794440PHASE2/PHASE3UNKNOWNA Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.
NCT03802240PHASE3COMPLETEDSintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
NCT03884192PHASE3UNKNOWNConsolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC
NCT04044222PHASE3UNKNOWNA Study to Evaluate the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus ICE Regimen in Classic Hodgkin’s Lymphoma Patients (cHL) Who Have Failed First-line Standard Chemotherapy
NCT04167293PHASE2/PHASE3UNKNOWNCombination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01)
NCT04277663PHASE3TERMINATEDThe Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

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:

MoleculeSourceStatusShared targets
PYRVINIUMChEMBLPhase 4 (approved)PDCD1
RIFABUTINChEMBLPhase 4 (approved)PDCD1
GefitinibPubChemApprovedPDCD1
PomalidomidePubChemApprovedPDCD1