Cadonilimab
drugOn this page
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
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4594456 |
| Name | Cadonilimab |
| Type | Antibody |
| Max phase | 3 |
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).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| CTLA4 | cytotoxic T-lymphocyte-associated protein 4 (CD152) | Binding | 10.1 | 0% | P16410 |
| PDCD1 | programmed cell death 1 (CD279) | Binding | 10.29 | 0% | 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:
| Pathway | Targets | Genes |
|---|---|---|
| Co-stimulation by CD28 | 1 | CTLA4 |
| Co-inhibition by CTLA4 | 1 | CTLA4 |
| Co-inhibition by PD-1 | 1 | PDCD1 |
| RUNX1 and FOXP3 control the development of regulatory T lymphocytes (Tregs) | 1 | CTLA4 |
| Potential therapeutics for SARS | 1 | PDCD1 |
| PD-L1(CD274) glycosylation and translocation to plasma membrane | 1 | PDCD1 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| adaptive immune response | 2 |
| negative regulation of T cell receptor signaling pathway | 2 |
| negative regulation of T cell activation | 2 |
| immune system process | 2 |
| immune response | 1 |
| DNA damage response | 1 |
| negative regulation of B cell proliferation | 1 |
| negative regulation of T cell proliferation | 1 |
| positive regulation of apoptotic process | 1 |
| negative regulation of regulatory T cell differentiation | 1 |
| T cell receptor signaling pathway | 1 |
| B cell receptor signaling pathway | 1 |
| regulation of T cell proliferation | 1 |
| B cell apoptotic process | 1 |
| negative regulation of tolerance induction | 1 |
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).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hepatocellular carcinoma | 3 | MONDO:0007256 | EFO:0000182 |
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| cervical carcinoma | 3 | MONDO:0005131 | EFO:0001061 |
| cervical adenocarcinoma | 3 | MONDO:0005153 | EFO:0001416 |
| adenocarcinoma | 3 | MONDO:0004970 | MONDO:0003219 |
| nasopharyngeal carcinoma | 3 | MONDO:0015459 | MONDO:0015459 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| nasopharyngeal neoplasm | 2 | MONDO:0005375 | EFO:0004252 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| lung neoplasm | 2 | MONDO:0021117 | MONDO:0008903 |
| colorectal carcinoma | 2 | MONDO:0024331 | EFO:1001951 |
| ovarian cancer | 2 | MONDO:0008170 | MONDO:0008170 |
| renal cell carcinoma | 2 | MONDO:0005086 | EFO:0000681 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| esophageal squamous cell carcinoma | 2 | MONDO:0005580 | EFO:0005922 |
| rectal cancer | 2 | MONDO:0006519 | EFO:1000657 |
| intrahepatic cholangiocarcinoma | 2 | MONDO:0003210 | EFO:1001961 |
| soft tissue sarcoma | 2 | MONDO:0018078 | EFO:1001968 |
| gastric neoplasm | 2 | MONDO:0021085 | MONDO:0001056 |
| rectal neoplasm | 2 | MONDO:0002165 | MONDO:0044937 |
| head and neck squamous cell carcinoma | 2 | MONDO:0010150 | EFO:0000181 |
| colorectal adenocarcinoma | 2 | MONDO:0005008 | EFO:0000365 |
| gastric adenocarcinoma | 2 | MONDO:0005036 | EFO:0000503 |
| mesothelioma | 2 | MONDO:0005065 | EFO:0000588 |
| urothelial carcinoma | 2 | MONDO:0040679 | EFO:0008528 |
| vulva cancer | 2 | MONDO:0001528 | MONDO:0001528 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| peripheral T-cell lymphoma, not otherwise specified | 1 | MONDO:0004964 | EFO:0000211 |
| glioblastoma | 1 | MONDO:0018177 | EFO:0000519 |
| small cell lung carcinoma | 1 | MONDO:0008433 | EFO: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
| Phase | Trials |
|---|---|
| PHASE2 | 105 |
| PHASE1/PHASE2 | 25 |
| PHASE3 | 14 |
| PHASE1 | 9 |
| Not specified | 6 |
| EARLY_PHASE1 | 3 |
| PHASE2/PHASE3 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04982237 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer |
| NCT05235516 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer |
| NCT05489289 | PHASE3 | RECRUITING | A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection |
| NCT05587374 | PHASE3 | ACTIVE_NOT_RECRUITING | Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE) |
| 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 |
| NCT06221748 | PHASE2/PHASE3 | RECRUITING | DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy |
| NCT06241599 | PHASE2/PHASE3 | RECRUITING | A 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) |
| NCT06341335 | PHASE3 | RECRUITING | A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma |
| NCT06371157 | PHASE3 | RECRUITING | A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma |
| NCT06542549 | PHASE3 | NOT_YET_RECRUITING | Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer |
| NCT06566755 | PHASE3 | RECRUITING | Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer |
| NCT06617416 | PHASE3 | RECRUITING | A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC |
| NCT06832917 | PHASE3 | NOT_YET_RECRUITING | Short-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) |
| NCT07023315 | PHASE3 | RECRUITING | A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma |
| NCT07412613 | PHASE3 | RECRUITING | Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer |
| NCT05008783 | PHASE3 | COMPLETED | A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma |
| NCT04556253 | PHASE2 | ACTIVE_NOT_RECRUITING | AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer |
| NCT04982276 | PHASE1/PHASE2 | RECRUITING | A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma |
| NCT05063916 | PHASE2 | ACTIVE_NOT_RECRUITING | Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix |
| NCT05142423 | PHASE1/PHASE2 | RECRUITING | A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors |
| NCT05215067 | PHASE2 | ACTIVE_NOT_RECRUITING | A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer |
| NCT05256472 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma |
| NCT05319431 | PHASE2 | ACTIVE_NOT_RECRUITING | A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC |
| NCT05377658 | PHASE2 | RECRUITING | AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer |
| NCT05426005 | PHASE1/PHASE2 | RECRUITING | Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer |
| NCT05571644 | PHASE2 | RECRUITING | Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer |
| NCT05732662 | PHASE2 | NOT_YET_RECRUITING | SBRT Combined With AK104 to Treatment Relapsed or Metastatic ESCC |
| NCT05747716 | PHASE2 | NOT_YET_RECRUITING | SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC |
| NCT05784974 | PHASE2 | NOT_YET_RECRUITING | Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer |
| NCT05794750 | PHASE2 | NOT_YET_RECRUITING | Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC(AK104-IIT-13) |
| NCT05808608 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma |
| NCT05816499 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | Cadonilimab in Patients (Pts) With Advanced Non-small Cell Lung Cancer (NSCLC) |
| NCT05817214 | PHASE2 | RECRUITING | Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer |
| NCT05824481 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer |
| NCT05824494 | PHASE2 | NOT_YET_RECRUITING | Cadonilimab Plus Nab -Paclitaxel for Patients With Recurrent, or Metastatic Cervical Cancer Resistant to Immune Checkpoint Inhibitors |
| NCT05833971 | PHASE2 | NOT_YET_RECRUITING | Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma |
| NCT05859750 | PHASE2 | RECRUITING | A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer |
| NCT05882370 | PHASE2 | RECRUITING | TIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study |
| NCT05896787 | PHASE2 | NOT_YET_RECRUITING | Candonilimab (AK104) Plus Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) |
| NCT05898256 | PHASE1/PHASE2 | NOT_YET_RECRUITING | Cadonilimab 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.
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 |