Sintilimab
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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
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297829 |
| Name | Sintilimab |
| Type | Antibody |
| Max phase | 3 |
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).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| PDCD1 | programmed cell death 1 (CD279) | Binding | 9.6 | 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
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).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hepatocellular carcinoma | 3 | MONDO:0007256 | EFO:0000182 |
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| nasopharyngeal neoplasm | 3 | MONDO:0005375 | EFO:0004252 |
| esophageal squamous cell carcinoma | 3 | MONDO:0005580 | EFO:0005922 |
| colorectal adenocarcinoma | 3 | MONDO:0005008 | EFO:0000365 |
| colorectal carcinoma | 3 | MONDO:0024331 | EFO:1001951 |
| gastric neoplasm | 3 | MONDO:0021085 | MONDO:0001056 |
| lung neoplasm | 3 | MONDO:0021117 | MONDO:0008903 |
| Hodgkins lymphoma | 3 | MONDO:0004952 | MONDO:0009348 |
| gastric adenocarcinoma | 3 | MONDO:0005036 | EFO:0000503 |
| breast neoplasm | 3 | MONDO:0021100 | MONDO:0007254 |
| carcinoma of esophagus | 3 | MONDO:0019086 | EFO:0002916 |
| colorectal neoplasm | 3 | MONDO:0005335 | EFO:0004142 |
| gastric carcinoma | 3 | MONDO:0004950 | EFO:0000178 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| small cell lung carcinoma | 2 | MONDO:0008433 | EFO:0000702 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| renal cell carcinoma | 2 | MONDO:0005086 | EFO:0000681 |
| sarcoma | 2 | MONDO:0005089 | EFO:0000691 |
| squamous cell carcinoma | 2 | MONDO:0005096 | EFO:0000707 |
| cervical adenocarcinoma | 2 | MONDO:0005153 | EFO:0001416 |
| primary cutaneous T-cell non-Hodgkin lymphoma | 2 | MONDO:0000607 | EFO:0002913 |
| oral cavity cancer | 2 | MONDO:0005515 | EFO:0005570 |
| ovarian cancer | 2 | MONDO:0008170 | MONDO:0008170 |
| nasal cavity and paranasal sinus lethal midline granuloma | 2 | MONDO:0006828 | MONDO:0019472 |
| oral cavity squamous cell carcinoma | 2 | MONDO:0004958 | EFO:0000199 |
| peripheral T-cell lymphoma, not otherwise specified | 2 | MONDO:0004964 | EFO:0000211 |
| clear cell adenocarcinoma | 2 | MONDO:0005004 | EFO:0000348 |
| neuroblastoma | 2 | MONDO:0005072 | EFO:0000621 |
| rectal cancer | 2 | MONDO:0006519 | EFO:1000657 |
| intrahepatic cholangiocarcinoma | 2 | MONDO:0003210 | EFO:1001961 |
| soft tissue sarcoma | 2 | MONDO:0018078 | EFO:1001968 |
| head and neck squamous cell carcinoma | 2 | MONDO:0010150 | EFO:0000181 |
| angioimmunoblastic T-cell lymphoma | 2 | MONDO:0004977 | EFO:0000255 |
| clear cell renal carcinoma | 2 | MONDO:0005005 | EFO:0000349 |
| endometrium neoplasm | 2 | MONDO:0021251 | MONDO:0011962 |
| mesothelioma | 2 | MONDO:0005065 | EFO:0000588 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| pancreatic neoplasm | 2 | MONDO:0021040 | EFO:0003860 |
| angiosarcoma | 2 | MONDO:0016982 | EFO:0003968 |
| cholangiocarcinoma | 2 | MONDO:0019087 | EFO:0005221 |
| neuroendocrine neoplasm | 2 | MONDO:0019496 | EFO:1001901 |
| undifferentiated pleomorphic sarcoma | 2 | MONDO:0002142 | EFO:1001972 |
| neuroendocrine carcinoma | 2 | MONDO:0002120 | MONDO:0002120 |
| salivary gland cancer | 2 | MONDO:0004669 | MONDO:0004669 |
| glioblastoma | 2 | MONDO:0018177 | EFO:0000519 |
| malignant pancreatic neoplasm | 2 | MONDO:0009831 | EFO:1000359 |
| gallbladder neoplasm | 2 | MONDO:0021253 | MONDO:0005411 |
| squamous cell lung carcinoma | 2 | MONDO:0005097 | EFO:0000708 |
| cervical carcinoma | 2 | MONDO:0005131 | EFO:0001061 |
| adenocarcinoma | 2 | MONDO:0004970 | MONDO:0003219 |
| nasopharyngeal carcinoma | 2 | MONDO:0015459 | MONDO:0015459 |
| carcinoma | 1 | MONDO:0004993 | EFO: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
| Phase | Trials |
|---|---|
| PHASE2 | 252 |
| PHASE1 | 39 |
| PHASE3 | 36 |
| PHASE1/PHASE2 | 27 |
| Not specified | 26 |
| PHASE2/PHASE3 | 8 |
| PHASE4 | 3 |
| EARLY_PHASE1 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05843292 | PHASE4 | NOT_YET_RECRUITING | Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer |
| NCT06761911 | PHASE4 | NOT_YET_RECRUITING | BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma |
| NCT07010393 | PHASE4 | NOT_YET_RECRUITING | Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study |
| NCT05116462 | PHASE3 | ACTIVE_NOT_RECRUITING | Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer |
| NCT05171660 | PHASE3 | ACTIVE_NOT_RECRUITING | Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer |
| NCT05236972 | PHASE3 | RECRUITING | PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer |
| NCT05244798 | PHASE3 | NOT_YET_RECRUITING | Sintilimab Plus NCT or NCRT Versus NCRT for ESCC |
| NCT05357846 | PHASE3 | RECRUITING | PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101) |
| NCT05429463 | PHASE3 | RECRUITING | Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ) |
| NCT05484024 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer |
| NCT05495152 | PHASE3 | RECRUITING | Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma |
| NCT05522231 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2) |
| NCT05549037 | PHASE3 | RECRUITING | Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC |
| NCT05593458 | PHASE3 | RECRUITING | Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1 |
| NCT05890742 | PHASE3 | ACTIVE_NOT_RECRUITING | A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer |
| NCT05918094 | PHASE3 | RECRUITING | Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma |
| NCT05976568 | PHASE2/PHASE3 | NOT_YET_RECRUITING | A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma |
| NCT06089369 | PHASE3 | NOT_YET_RECRUITING | Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion |
| NCT06089382 | PHASE3 | NOT_YET_RECRUITING | A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection |
| NCT06497985 | PHASE3 | RECRUITING | A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients |
| NCT06584032 | PHASE3 | RECRUITING | Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer |
| NCT06618664 | PHASE3 | RECRUITING | A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma |
| NCT06900218 | PHASE3 | NOT_YET_RECRUITING | PD-1 Antibody Sintilimab Combined With Capecitabine as Adjuvant Therapy for High-Risk Nasopharyngeal Carcinoma |
| NCT07186621 | PHASE3 | RECRUITING | Adjuvant Radiotherapy of Sintilimab Versus TACE for HCC |
| NCT07306663 | PHASE3 | ACTIVE_NOT_RECRUITING | Sintilimab Combined With Chemotherapy Induction Therapy Followed by CCRT vs. CCRT for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study |
| NCT07459296 | PHASE3 | RECRUITING | Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC |
| NCT07490262 | PHASE2/PHASE3 | RECRUITING | A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. |
| NCT07537946 | PHASE3 | NOT_YET_RECRUITING | Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer |
| NCT03150875 | PHASE3 | COMPLETED | A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC |
| NCT03607539 | PHASE3 | COMPLETED | Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC |
| NCT03629925 | PHASE3 | COMPLETED | Sintilimab in Combination With Gemcitabine and Platinum-Based Chemotherapy as First-Line Therapy for Advanced or Metastatic Squamous NSCLC |
| NCT03700476 | PHASE3 | UNKNOWN | Sintilimab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma |
| NCT03745170 | PHASE3 | COMPLETED | Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer |
| NCT03748134 | PHASE3 | COMPLETED | Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 ) |
| NCT03794440 | PHASE2/PHASE3 | UNKNOWN | A 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. |
| NCT03802240 | PHASE3 | COMPLETED | Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure |
| NCT03884192 | PHASE3 | UNKNOWN | Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC |
| NCT04044222 | PHASE3 | UNKNOWN | A 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 |
| NCT04167293 | PHASE2/PHASE3 | UNKNOWN | Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01) |
| NCT04277663 | PHASE3 | TERMINATED | The 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.
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 |
Related Atlas pages
- Genes: PDCD1
- Diseases: hepatocellular carcinoma, non-small cell lung carcinoma, nasopharyngeal neoplasm, esophageal squamous cell carcinoma, colorectal adenocarcinoma, colorectal carcinoma, gastric neoplasm, lung neoplasm, Hodgkins lymphoma, gastric adenocarcinoma, breast neoplasm, carcinoma of esophagus, colorectal neoplasm, gastric carcinoma
- Drugs: Pyrvinium, Rifabutin, Gefitinib, Pomalidomide