marked.bio

PD-1/CTLA-4 bispecific antibody · bispecific antibody

cadonilimab

10 active trials across 6 of our biomarkers, targeting PD-1 x CTLA-4. Not approved for any biomarker on marked.bio yet.

Also known as AK104.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MSI-H / dMMR 4 7 Phase 3
Claudin 18.2 expression 3 3 Phase 2
KRAS G12C 2 2 Phase 3
KRAS G12D 2 2 Phase 3
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 1 Phase 1/2
HER2 (ERBB2) activating mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of cadonilimab.

  1. Akeso 1

Trials

10 of 14 trials shown

  1. Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

    Recruiting Phase 3 Akeso Started 2026Primary completion 2030-06 NCT07412613

    cadonilimaboxaliplatincapecitabinefluorouracilleucovorin

    Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17…

    MSI-H / dMMRResectable Colon Cancer, MSI-H/dMMR Colorectal Cancer

  2. Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer

    Recruiting Phase 3 Caigang Liu Started 2024Primary completion 2026-02 NCT06566755

    cadonilimabbevacizumab

    Genetic testing revealed RAS (including KRAS and NRAS) mutations, or primary sites located in the right half of the colon (including cecum, rising Colon a…

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-08-22Colorectal Cancer

  3. LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study

    Recruiting Phase 2 Ruijin Hospital Started 2026Primary completion 2028-04 NCT07556640

    LM-302paclitaxelcadonilimab

    Claudin 18.2 positive (≥ 25%, moderate to strong staining);

    Claudin 18.2 expressionGastric Cancer Stage IV, Peritoneal Metastases From Gastric Cancer, Gastric or Esophagogastric Junction Adenocarcinoma

  4. Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis

    Recruiting Phase 2 Ruijin Hospital Started 2025Primary completion 2027-01 NCT06519591

    cadonilimabLM-302paclitaxel

    Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accou…

    Claudin 18.2 expressionGastric Cancer Stage IV, Peritoneal Metastases

  5. Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC

    Recruiting Phase 2 Fudan University Started 2025Primary completion 2027-05 NCT07003022

    cadonilimabbevacizumabregorafenibfruquintinib

    Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytological examination combined w…

    MSI-H / dMMRColo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

  6. Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer

    Recruiting Phase 2 Fudan University Started 2024Primary completion 2025-12 NCT06218810

    cadonilimabbevacizumabFOLFOX

    RAS mutation;

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-01-23Metastatic Colorectal Cancer, Microsatellite Stable Colorectal Carcinoma, RAS Mutation, Cadonilimab

  7. Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

    Recruiting Phase 1/2 Zhejiang Cancer Hospital Started 2024Primary completion 2026-08 NCT06650332

    cadonilimabtrastuzumabXELOXdisitamab vedotinmFOLFOX6

    Cohort 3: HER2 low expression, defined as IHC 1+ or IHC 2+ but ISH or FISH negative.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-10-21Metastatic HER2 Positive Gastroesophageal Junction Cancer

  8. The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Shanghai Zhongshan Hospital Started 2024Primary completion 2025-07 NCT06587425

    LM-302capecitabinecadonilimab

    CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testin…

    Claudin 18.2 expressionStatus may be outdated, last updated 2024-09-19Gastric or Gastroesophageal Junction Adenocarcinoma

  9. AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

    Active, not recruiting Phase 2 Peking University Started 2024Primary completion 2026-12 NCT04556253

    cadonilimab

    AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

    MSI-H / dMMRMSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

  10. Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer

    Active, not recruiting Phase 1/2 Sun Yat-sen University Started 2023Primary completion 2026-09 NCT05426005

    cadonilimab

    …deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).

    MSI-H / dMMRColorectal Cancer Stage IV, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H)