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    DRUG CLASS:

    CTLA4 antagonist

    Related drugs:
    21h
    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)
    1d
    The Seven Trial: Exploiting the Unfolded Protein Response (clinicaltrials.gov)
    P1, N=6, Terminated, HonorHealth Research Institute | Trial completion date: Dec 2026 --> Dec 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Dec 2025; The study was terminated early per the recommendation of the Data and Safety Monitoring Board (DSMB) after a planned interim analysis met pre-specified criteria for futility.
    Trial completion date • Trial termination • Trial primary completion date
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • celecoxib oral • chloroquine phosphate
    7d
    Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3 (clinicaltrials.gov)
    P2, N=100, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    10d
    Transcriptomic profiling identifies immunotherapy-responsive phenotypes in microsatellite-stable metastatic colorectal cancer. (PubMed, Oncogene)
    We present a comprehensive transcriptomics analysis of metastatic and primary tumor biopsies from MSS mCRC patients treated with botensilimab (BOT; Fc-enhanced anti-CTLA-4) ± balstilimab (BAL; anti-PD-1). This study identified distinct tumor microenvironment states that align along an immunophenotype axis marked by CD74, interferon-γ, and APOBEC3 expression identified previously for primary CRC. Our findings provide novel insights into molecular correlates of immunotherapy response in MSS mCRC, potentially informing future therapeutic strategies to expand ICI efficacy to historically unresponsive tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD74 (CD74 Molecule) • IFNG (Interferon, gamma)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    14d
    A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=81, Completed, Agenus Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • botensilimab (AGEN1181)
    17d
    Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Immune Oncology Research Institute | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK rearrangement
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, Weill Medical College of Cornell University | Suspended --> Active, not recruiting
    Enrollment closed
    |
    MSI-H/dMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    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)
    1m
    Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, City of Hope Medical Center
    New P2 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Botensilimab, Balstilimab, and SBRT in Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting
    Enrollment open • MSI-H • pMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Northwestern University | Trial completion date: Aug 2026 --> Aug 2031 | Trial primary completion date: May 2026 --> Jul 2031
    Trial completion date • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    SHR-8068-301: A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=590, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial primary completion date: Mar 2026 --> Sep 2026
    Trial primary completion date
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Tyvyt (sintilimab) • CS1002 (ipilimumab biosimilar) • AiRuiLi (adebrelimab)