Cadonilimab

drug
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Also known as Ak-104Ak104

Summary

Cadonilimab (CHEMBL4594456) is a phase-3 clinical-stage antibody targeting CTLA4 and PDCD1; indicated across 37 conditions including hepatocellular carcinoma and non-small cell lung carcinoma.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Antibody
  • Targets: 2 (CTLA4, PDCD1)
  • Indications: 37 conditions
  • Clinical trials: 164

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL4594456
NameCadonilimab
TypeAntibody
Max phase3

Also known as: Ak-104, AK-104, Ak104, AK104, Cadonilimab, CADONILIMAB

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
CTLA4cytotoxic T-lymphocyte-associated protein 4 (CD152)Binding10.10%P16410
PDCD1programmed cell death 1 (CD279)Binding10.290%Q15116

Bioactivity

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

Target pathways

Aggregated over 2 target gene(s): CTLA4, PDCD1.

Top Reactome pathways

6 total, by targets touching each:

PathwayTargetsGenes
Co-stimulation by CD281CTLA4
Co-inhibition by CTLA41CTLA4
Co-inhibition by PD-11PDCD1
RUNX1 and FOXP3 control the development of regulatory T lymphocytes (Tregs)1CTLA4
Potential therapeutics for SARS1PDCD1
PD-L1(CD274) glycosylation and translocation to plasma membrane1PDCD1

Dominant GO biological processes

GO termTargets
adaptive immune response2
negative regulation of T cell receptor signaling pathway2
negative regulation of T cell activation2
immune system process2
immune response1
DNA damage response1
negative regulation of B cell proliferation1
negative regulation of T cell proliferation1
positive regulation of apoptotic process1
negative regulation of regulatory T cell differentiation1
T cell receptor signaling pathway1
B cell receptor signaling pathway1
regulation of T cell proliferation1
B cell apoptotic process1
negative regulation of tolerance induction1

Indications & clinical

Indications

37 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
cervical carcinoma3MONDO:0005131EFO:0001061
cervical adenocarcinoma3MONDO:0005153EFO:0001416
adenocarcinoma3MONDO:0004970MONDO:0003219
nasopharyngeal carcinoma3MONDO:0015459MONDO:0015459
melanoma2MONDO:0005105EFO:0000756
nasopharyngeal neoplasm2MONDO:0005375EFO:0004252
neoplasm2MONDO:0005070EFO:0000616
lung neoplasm2MONDO:0021117MONDO:0008903
colorectal carcinoma2MONDO:0024331EFO:1001951
ovarian cancer2MONDO:0008170MONDO:0008170
renal cell carcinoma2MONDO:0005086EFO:0000681
exocrine pancreatic carcinoma2MONDO:0005192EFO:0002618
esophageal squamous cell carcinoma2MONDO:0005580EFO:0005922
rectal cancer2MONDO:0006519EFO:1000657
intrahepatic cholangiocarcinoma2MONDO:0003210EFO:1001961
soft tissue sarcoma2MONDO:0018078EFO:1001968
gastric neoplasm2MONDO:0021085MONDO:0001056
rectal neoplasm2MONDO:0002165MONDO:0044937
head and neck squamous cell carcinoma2MONDO:0010150EFO:0000181
colorectal adenocarcinoma2MONDO:0005008EFO:0000365
gastric adenocarcinoma2MONDO:0005036EFO:0000503
mesothelioma2MONDO:0005065EFO:0000588
urothelial carcinoma2MONDO:0040679EFO:0008528
vulva cancer2MONDO:0001528MONDO:0001528
colorectal neoplasm2MONDO:0005335MONDO:0005575
breast neoplasm2MONDO:0021100MONDO:0007254
peripheral T-cell lymphoma, not otherwise specified1MONDO:0004964EFO:0000211
glioblastoma1MONDO:0018177EFO:0000519
small cell lung carcinoma1MONDO:0008433EFO:0000702

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

Clinical trials

Total trials: 164.

Phase distribution

PhaseTrials
PHASE2105
PHASE1/PHASE225
PHASE314
PHASE19
Not specified6
EARLY_PHASE13
PHASE2/PHASE32

Top trials by phase / activity

NCTPhaseStatusTitle
NCT04982237PHASE3ACTIVE_NOT_RECRUITINGA Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
NCT05235516PHASE3ACTIVE_NOT_RECRUITINGA Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer
NCT05489289PHASE3RECRUITINGA Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
NCT05587374PHASE3ACTIVE_NOT_RECRUITINGCadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE)
NCT05990127PHASE3NOT_YET_RECRUITINGA Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer
NCT06221748PHASE2/PHASE3RECRUITINGDV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
NCT06241599PHASE2/PHASE3RECRUITINGA Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
NCT06341335PHASE3RECRUITINGA Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06371157PHASE3RECRUITINGA Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
NCT06542549PHASE3NOT_YET_RECRUITINGEfficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer
NCT06566755PHASE3RECRUITINGCadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
NCT06617416PHASE3RECRUITINGA Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
NCT06832917PHASE3NOT_YET_RECRUITINGShort-course Radiation (SCRT) Followed by 6 Cycles of Cadonilimab Plus MFOLFOX6 As Neoadjuvant Therapy for Patients with Locally Advanced Rectal Cancer (LARC): a Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Trial (NeoCaCRT-III)
NCT07023315PHASE3RECRUITINGA Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
NCT07412613PHASE3RECRUITINGNeoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
NCT05008783PHASE3COMPLETEDA Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
NCT04556253PHASE2ACTIVE_NOT_RECRUITINGAK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
NCT04982276PHASE1/PHASE2RECRUITINGA Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
NCT05063916PHASE2ACTIVE_NOT_RECRUITINGPhase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix
NCT05142423PHASE1/PHASE2RECRUITINGA Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
NCT05215067PHASE2ACTIVE_NOT_RECRUITINGA Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer
NCT05256472PHASE2ACTIVE_NOT_RECRUITINGA Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma
NCT05319431PHASE2ACTIVE_NOT_RECRUITINGA Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
NCT05377658PHASE2RECRUITINGAK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
NCT05426005PHASE1/PHASE2RECRUITINGCadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer
NCT05571644PHASE2RECRUITINGNeoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer
NCT05732662PHASE2NOT_YET_RECRUITINGSBRT Combined With AK104 to Treatment Relapsed or Metastatic ESCC
NCT05747716PHASE2NOT_YET_RECRUITINGSBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC
NCT05784974PHASE2NOT_YET_RECRUITINGCadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
NCT05794750PHASE2NOT_YET_RECRUITINGAssess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC(AK104-IIT-13)
NCT05808608PHASE1/PHASE2ACTIVE_NOT_RECRUITINGA Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
NCT05816499PHASE1/PHASE2ACTIVE_NOT_RECRUITINGCadonilimab in Patients (Pts) With Advanced Non-small Cell Lung Cancer (NSCLC)
NCT05817214PHASE2RECRUITINGCadonilimab Plus Anlotinib for R/M/P Cervical Cancer
NCT05824481PHASE2ACTIVE_NOT_RECRUITINGStudy of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer
NCT05824494PHASE2NOT_YET_RECRUITINGCadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors
NCT05833971PHASE2NOT_YET_RECRUITINGCadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
NCT05859750PHASE2RECRUITINGA Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
NCT05882370PHASE2RECRUITINGTIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study
NCT05896787PHASE2NOT_YET_RECRUITINGCandonilimab (AK104) Plus Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
NCT05898256PHASE1/PHASE2NOT_YET_RECRUITINGCadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

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