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    DRUG CLASS:

    CTLA4 antagonist

    Related drugs:
    2d
    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)
    5d
    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)
    9d
    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)
    12d
    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)
    29d
    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)
    29d
    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)
    2ms
    Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Signatera™
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    A Phase Ib/II Clinical Trial of Anti-PD1/Anti-CTLA4 Antibodies Combined with Azacitidine and Venetoclax in Newly Diagnosed Elderly or Intensive Chemotherapy-Unfit Acute Myeloid Leukemia or Relapsed/Refractory Acute Myeloid Leukemia (ChiCTR2600119729)
    P4, N=69, Sun Yat-Sen University Cancer Center; Sun Yat-Sen University Cancer Center
    New P4 trial
    |
    Venclexta (venetoclax) • azacitidine • Qibeian (iparomlimab/tuvonralimab)