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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
    Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, Ruijin Hospital
    New P2 trial
    |
    Kaitanni (cadonilimab)
    2d
    A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • Kaitanni (cadonilimab) • Yidafan (ivonescimab) • lancastotug (AK127)
    3d
    A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=422, Not yet recruiting, Akeso
    New P3 trial
    |
    capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    3d
    Cadonilimab (PD-1/CTLA-4 bispecific antibody) combination therapy for driver gene-negative advanced NSCLC: a single-center retrospective real-world study. (PubMed, Front Oncol)
    This study confirms the promising efficacy and acceptable safety profile of AK104 combination therapy in patients with driver gene-negative advanced NSCLC. These findings collectively support the need for further large-scale prospective studies to validate its clinical utility.
    Retrospective data • Journal • Real-world evidence
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • PD-L1 negative
    |
    Kaitanni (cadonilimab)
    3d
    THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, University of Texas Southwestern Medical Center
    New P1 trial
    |
    Kaitanni (cadonilimab) • ateganosine (THIO)
    8d
    Clinical trials of bispecific antibody therapy for colorectal cancer: advanced and next steps. (PubMed, Front Oncol)
    In contrast to resource-intensive CAR-T or payload-driven ADCs, BsAbs provide a ready-to-use therapeutic format that simultaneously engages two antigens, offering distinct practical and mechanistic benefits. In the future, it is necessary to further optimize the design of BsAbs, explore combination therapies and identify predictive biomarkers to promote its clinical transformation and improve the prognosis of CRC patients.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Kaitanni (cadonilimab)
    16d
    ZSAB-Calm: Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody (clinicaltrials.gov)
    P1/2, N=78, Active, not recruiting, Shanghai Zhongshan Hospital | Recruiting --> Active, not recruiting | Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2025 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CLDN18 (Claudin 18) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Kaitanni (cadonilimab)
    16d
    A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence (clinicaltrials.gov)
    P2, N=45, Terminated, Guangxi Medical University | Not yet recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2025; The support from the relevant company was not obtained as planned
    Trial termination • Trial primary completion date
    |
    Kaitanni (cadonilimab)
    17d
    Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer (clinicaltrials.gov)
    P3, N=386, Not yet recruiting, Akeso
    New P3 trial • Mismatch repair • MSI-H • dMMR
    |
    MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    MSI-H/dMMR
    |
    5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Kaitanni (cadonilimab)
    24d
    AK104-310: A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma (clinicaltrials.gov)
    P3, N=760, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    oxaliplatin • Kaitanni (cadonilimab) • Teysuno (gimeracil/oteracil/tegafur)
    24d
    A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT (clinicaltrials.gov)
    P3, N=378, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New P3 trial
    |
    cisplatin • albumin-bound paclitaxel • Kaitanni (cadonilimab)
    25d
    AK104-IIT-C-N1-0004: A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Recruiting --> Active, not recruiting | Trial completion date: Nov 2025 --> Nov 2026
    Enrollment closed • Trial completion date
    |
    Stivarga (regorafenib) • Kaitanni (cadonilimab)