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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
    CSWOG-C03: Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting
    Enrollment closed • Mismatch repair • MSI-H • dMMR
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Kaitanni (cadonilimab)
    3d
    Cadonilimab in the treatment of advanced metastatic soft tissue clear cell sarcoma achieved complete remission: a case report. (PubMed, Front Oncol)
    After transient benefit from first-line doxorubicin plus ifosfamide chemotherapy, the disease progressed despite second-line PD-1 inhibitor combined with anlotinib. Treatment was subsequently switched to cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination therapy, resulting in a progression-free survival of more than 24 months. This outcome appears encouraging compared with previously reported CCS benchmarks; however, given the single-case nature and combined treatment strategy, the specific contribution of cadonilimab should be interpreted with caution.
    Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Focus V (anlotinib) • doxorubicin hydrochloride • ifosfamide • Kaitanni (cadonilimab)
    8d
    Sustained complete response to TMEp-CI-M platform in refractory small-cell lung cancer with brainstem metastasis: a case report with over 20 months of disease-free survival. (PubMed, Front Immunol)
    The TMEp phase integrated stereotactic body radiotherapy (SBRT), low-dose etoposide, and anlotinib, followed by CI with the programmed death 1 (PD-1)/cytotoxic T lymphocyte antigen 4 (CTLA-4) bispecific antibody cadonilimab and concurrent probiotic supplementation...The TMEp-CI-M platform may enhance the efficacy of immunotherapy in ES-SCLC, enabling durable responses even in patients with brainstem metastases. Although this platform has demonstrated promise across multiple tumor types, further prospective and mechanistic studies are warranted to confirm its clinical utility.
    Journal
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 negative
    |
    Focus V (anlotinib) • etoposide IV • Kaitanni (cadonilimab)
    9d
    Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial (clinicaltrials.gov)
    P2, N=134, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University
    New P2 trial
    |
    Kaitanni (cadonilimab)
    13d
    Cadonilimab plus chemotherapy as first-line treatment in PD-L1-negative advanced non-small cell lung cancer: a phase II clinical trial. (PubMed, Nat Commun)
    Baseline differentially methylated fragments scores show a significant correlation with PFS, with low-risk patients demonstrating a longer median PFS compared to high-risk patients (11.4 months versus 6.9 months). Overall, first-line cadonilimab plus chemotherapy shows an encouraging efficacy with a manageable safety profile for challenging-to-treat PD-L1-negative advanced NSCLC, warranting further evaluation in controlled studies.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • PD-L1 overexpression • PD-L1 negative
    |
    Kaitanni (cadonilimab)
    14d
    AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=128, Completed, Akeso | Trial completion date: Mar 2024 --> May 2026 | Trial primary completion date: Mar 2023 --> May 2026 | Recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    cisplatin • paclitaxel • docetaxel • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • Kaitanni (cadonilimab) • ligufalimab (AK117)
    15d
    AK104-215: A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=44, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Jan 2026 | Trial primary completion date: Jun 2025 --> Jan 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    docetaxel • Kaitanni (cadonilimab)
    15d
    A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC (clinicaltrials.gov)
    P1/2, N=36, Completed, Sun Yat-sen University | Trial completion date: Feb 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Mar 2026 | Active, not recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    Stivarga (regorafenib) • Kaitanni (cadonilimab)
    16d
    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)
    20d
    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)
    21d
    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)
    24d
    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)