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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:
    7d
    Preclinical imaging evaluation of a bispecific antibody targeting hPD1/CTLA4 using humanized mice. (PubMed, Biomed Pharmacother)
    The results demonstrated the potential of translating 124I-AK104 into a method for screening patients who benefit from immunotherapy and the efficacy, as well as the feasibility, of this method was verified by immuno-PET imaging of humanized mice.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    CTLA4 expression
    |
    Kaitanni (cadonilimab)
    10d
    Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma (clinicaltrials.gov)
    P2, N=28, Recruiting, Zhejiang Cancer Hospital
    New P2 trial • Metastases
    |
    Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    10d
    AK104-206: A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=59, Completed, Akeso | Recruiting --> Completed | N=30 --> 59 | Trial primary completion date: Apr 2023 --> Nov 2023
    Trial completion • Enrollment change • Trial primary completion date • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    10d
    A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P2, N=50, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Feb 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • Kaitanni (cadonilimab)
    10d
    A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=198, Recruiting, Akeso | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Feb 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Kaitanni (cadonilimab) • pulocimab (AK109)
    10d
    A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=32, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Mar 2023 --> Aug 2023
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    10d
    A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=46, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type
    |
    carboplatin • paclitaxel • pemetrexed • Kaitanni (cadonilimab)
    16d
    Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer (clinicaltrials.gov)
    P2, N=35, Recruiting, Zhongnan Hospital | Trial completion date: Mar 2025 --> Feb 2027 | Trial primary completion date: Oct 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    18d
    Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment (clinicaltrials.gov)
    P2, N=27, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Feb 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
    Enrollment open • Trial initiation date • Trial primary completion date • Metastases
    |
    Focus V (anlotinib) • Kaitanni (cadonilimab)
    18d
    A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=469, Not yet recruiting, Akeso
    New P3 trial • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    19d
    A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=53, Not yet recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    doxorubicin hydrochloride • Kaitanni (cadonilimab)
    19d
    Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=27, Recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    Kaitanni (cadonilimab)
    20d
    Cadonilimab in Combination With Ramucirumab for the Treatment of Advanced Hepatocellular Carcinoma That Has Failed at Systemic Therapy (clinicaltrials.gov)
    P1, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Phase classification: P2 --> P1 | Initiation date: Jun 2023 --> Jun 2024
    Phase classification • Trial initiation date • Combination therapy • Metastases
    |
    Cyramza (ramucirumab) • Kaitanni (cadonilimab)
    22d
    Good response of cadonilimab (PD-1/CTLA-4 Bi-specific antibody) to patients with advanced lung adenocarcinoma after immunotherapy resistance: A case report. (PubMed, Asian J Surg)
    No abstract available
    Journal • Metastases
    |
    PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Kaitanni (cadonilimab)
    23d
    SCALE: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Hui-Chuan Sun
    New P2 trial
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    1m
    Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer (clinicaltrials.gov)
    P2, N=59, Not yet recruiting, West China Hospital
    New P2 trial • Metastases
    |
    albumin-bound paclitaxel • Kaitanni (cadonilimab)
    1m
    A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma (clinicaltrials.gov)
    P3, N=610, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2024 --> Aug 2024
    Enrollment closed • Trial primary completion date • Metastases
    |
    capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    1m
    DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov)
    P2/3, N=90, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    1m
    To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=30, Recruiting, Guangzhou Institute of Respiratory Disease
    New P2 trial
    |
    STK11 (Serine/threonine kinase 11)
    |
    Kaitanni (cadonilimab)
    1m
    A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=506, Not yet recruiting, Akeso
    New P3 trial
    |
    paclitaxel • Kaitanni (cadonilimab) • pulocimab (AK109)
    1m
    Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking Union Medical College Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    1m
    HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC (clinicaltrials.gov)
    P2, N=45, Recruiting, Fudan University
    New P2 trial
    |
    Stivarga (regorafenib) • oxaliplatin • Kaitanni (cadonilimab)
    1m
    A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=30, Recruiting, Guangzhou Institute of Respiratory Disease
    New P2 trial • Metastases
    |
    STK11 (Serine/threonine kinase 11)
    |
    Kaitanni (cadonilimab)
    1m
    Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Nanfang Hospital, Southern Medical University | Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    1m
    A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours (clinicaltrials.gov)
    P1, N=143, Recruiting, Akesobio Australia Pty Ltd | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    Kaitanni (cadonilimab) • AK127
    2ms
    Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial • Metastases
    |
    capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    2ms
    Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006) (clinicaltrials.gov)
    P2, N=46, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CD8 (cluster of differentiation 8) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • NCAM1 (Neural cell adhesion molecule 1) • CD68 (CD68 Molecule)
    |
    cisplatin • paclitaxel • Kaitanni (cadonilimab)
    2ms
    AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=233, Recruiting, Akeso | N=148 --> 233
    Enrollment change • Metastases
    |
    carboplatin • paclitaxel • docetaxel • pemetrexed • Kaitanni (cadonilimab) • ivonescimab (AK112)
    2ms
    Cadonilimab plus chemotherapy versus chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (COMPASSION-15): A randomized, double-blind, phase 3 trial (AACR 2024)
    Cadonilimab plus chemo showed significant improvement in OS and PFS regardless of PD-L1 status and manageable safety profile, which could be a new standard first-line treatment option for advanced G/GEJ adenocarcinoma.Cutoff date: Aug 18, 2023
    P3 data • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • PD-L1-L
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Kaitanni (cadonilimab)
    2ms
    Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Tongji Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • paclitaxel • Kaitanni (cadonilimab)
    2ms
    A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Meng Chao Hepatobiliary Hospital of Fujian Medical University
    New P2 trial
    |
    AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Stivarga (regorafenib) • Kaitanni (cadonilimab)
    2ms
    Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI (clinicaltrials.gov)
    P2, N=20, Recruiting, Guangzhou University of Traditional Chinese Medicine
    New P2 trial
    |
    Focus V (anlotinib) • pemetrexed • Kaitanni (cadonilimab)
    2ms
    Efficacy and safety of cadonilimab in previously treated recurrent or metastatic nasopharyngeal carcinoma(COMPASSION-06): A phase II multicenter study. (PubMed, Oral Oncol)
    Cadonilimab monotherapy demonstrated a promising efficacy and manageable toxicity in patients with previously treated R-M/NPC and provide an efficacious salvage treatment option.
    Clinical • P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Kaitanni (cadonilimab)
    2ms
    Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma (clinicaltrials.gov)
    P2, N=38, Recruiting, Sun Yat-sen University | Initiation date: Jul 2023 --> Nov 2023 | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date • Combination therapy
    |
    Avastin (bevacizumab) • carboplatin • pemetrexed • Kaitanni (cadonilimab)
    3ms
    Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases (clinicaltrials.gov)
    P=N/A, N=80, Recruiting, Sun Yat-sen University
    New trial
    |
    Avastin (bevacizumab) • Kaitanni (cadonilimab)
    3ms
    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) (clinicaltrials.gov)
    P2/3, N=300, Recruiting, Sun Yat-sen University
    New P2/3 trial • Combination therapy • Metastases
    |
    cisplatin • Kaitanni (cadonilimab)
    3ms
    A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, West China Second University Hospital
    New P2 trial • Metastases
    |
    Kaitanni (cadonilimab)
    3ms
    CD74 is associated with inflamed tumor immune microenvironment and predicts responsiveness to PD-1/CTLA-4 bispecific antibody in patients with solid tumors. (PubMed, Cancer Immunol Immunother)
    Our findings demonstrate that CD74 is a promising predictive biomarker for AK104 therapeutic response in advanced solid tumors. Trial registration number NCT03261011.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • CD74 (CD74 Molecule) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Kaitanni (cadonilimab)
    3ms
    DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov)
    P2/3, N=90, Not yet recruiting, RemeGen Co., Ltd.
    New P2/3 trial • Metastases
    |
    paclitaxel • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    3ms
    Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=53, Recruiting, Fudan University
    New P2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • leucovorin calcium • Kaitanni (cadonilimab)
    3ms
    A Phase II, Single-arm, Multicenter, Prospective Study of Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Peking Union Medical College Hospital
    New P2 trial
    |
    Lenvima (lenvatinib) • Kaitanni (cadonilimab)
    4ms
    Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin • Kaitanni (cadonilimab)