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    DRUG:

    Kaitanni (cadonilimab)

    i
    Other names: AK104, AK-104, AK 104
    Company:
    Akesobio
    Drug class:
    PD1 inhibitor, CTLA4 inhibitor
    Related drugs:
    1d
    Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, West China Hospital
    New P2 trial
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    5d
    A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)
    P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 negative
    |
    Kaitanni (cadonilimab)
    6d
    CATPCC-01: Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting --> Active, not recruiting | Trial completion date: Oct 2027 --> Apr 2029
    Enrollment closed • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • albumin-bound paclitaxel • Kaitanni (cadonilimab)
    9d
    A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations (clinicaltrials.gov)
    P1, N=158, Not yet recruiting, Akeso
    New P1 trial
    |
    Kaitanni (cadonilimab)
    16d
    PRaG5.0 combined with chemotherapy and sequential chemoimmunotherapy for massive SMARCA4-deficient undifferentiated tumor of the cervix: case report. (PubMed, Front Immunol)
    This regimen employs short-course stereotactic body radiotherapy (SBRT, 24Gy/3Fx) as the radiotherapy component, combined with cadonilimab (a PD-1/CTLA-4 bispecific antibody), GM-CSF and thymosin α1 to form the PRaG5.0, alongside chemotherapy with nab-paclitaxel...The patient's progression-free survival (PFS) now exceeds 12 months. This case indicates that for massive, refractory cervical tumors, PRaG5.0 combined with chemotherapy followed by sequential chemoimmunotherapy may offer an effective approach for controlling disease and extending survival.
    Journal
    |
    PD-1 (Programmed cell death 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CSF2 (Colony stimulating factor 2)
    |
    albumin-bound paclitaxel • Kaitanni (cadonilimab) • Zadaxin (thymalfasin)
    19d
    CSWOG-C03: Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Sun Yat-sen University | Trial completion date: Jul 2027 --> Dec 2028 | Trial primary completion date: Jul 2025 --> Sep 2026
    Trial completion date • Trial primary completion date • Mismatch repair • MSI-H • dMMR
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Kaitanni (cadonilimab)
    19d
    Cadonilimab induction and consolidation for unresectable stage III non-small cell lung cancer patients receiving concurrent chemoradiation: safety run-in results of a prospective, phase II trial. (PubMed, Transl Lung Cancer Res)
    Concurrent chemoradiotherapy (cCRT) followed by durvalumab consolidation remains the standard of care for unresectable stage III non-small cell lung cancer (NSCLC)...Cadonilimab (AK104), a bispecific antibody targeting programmed death 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4), has shown promising efficacy in advanced NSCLC...Most TRAEs were mild; however, 10 (50.0%) patients experienced grade 3-4 non-hematologic TRAEs. Cadonilimab induction and consolidation therapy demonstrated a manageable safety profile in patients with stage III NSCLC, supporting continued enrollment in this ongoing trial.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Imfinzi (durvalumab) • Kaitanni (cadonilimab)
    24d
    SFRT combined with immunotherapy for bulky hepatic metastasis from pancreatic acinar cell carcinoma: a case report. (PubMed, Front Oncol)
    The patient received Lattice SFRT (40 Gy in four fractions) to the hepatic lesion, combined with the PD-1/CTLA-4 bispecific antibody cadonilimab and the multi-targeted tyrosine kinase inhibitor anlotinib...The combination of Lattice SFRT, dual immune checkpoint blockade, and targeted therapy appears feasible and well-tolerated in this patient. Further clinical trials are warranted to validate this combined approach.
    Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    26d
    Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III/IV Melanoma. (clinicaltrials.gov)
    P1, N=10, Recruiting, Xijing Hospital
    New P1 trial • Tumor mutational burden
    |
    PD-L1 (Programmed death ligand 1) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    Kaitanni (cadonilimab)
    29d
    Real-world efficacy, safety, and associated biomarkers of cadonilimab in cervical cancer: a prospective observational study. (PubMed, Front Immunol)
    To evaluate the real-world efficacy and safety of cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4) in combination with chemotherapy with or without bevacizumab for cervical cancer and to identify potential biomarkers...In this real-world cohort, cadonilimab showed promising early efficacy and a manageable safety profile in cervical cancer. Identified biomarkers for response and immune-related dermal toxicity require validation in larger, prospective studies with longer follow-up.
    Observational data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
    |
    IL6 (Interleukin 6) • CD4 (CD4 Molecule) • IL17A (Interleukin 17A)
    |
    Avastin (bevacizumab) • Kaitanni (cadonilimab)
    1m
    IC Plus Low-dose Radiation Plus Cadonilimab in LANPC (clinicaltrials.gov)
    P3, N=380, Recruiting, Sun Yat-sen University | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial primary completion date
    |
    cisplatin • gemcitabine • Kaitanni (cadonilimab)
    1m
    CLEAR-IT: Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, RenJi Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)