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    DRUG:

    botensilimab (AGEN1181)

    i
    Other names: AGEN1181, AGEN 1181, AGEN-1181
    Company:
    Agenus, Zydus Lifesciences
    Drug class:
    CTLA4 antagonist
    Related drugs:
    2d
    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)
    19d
    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)
    22d
    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)
    24d
    A Phase 1b Study of Botensilimab and Balstilimab in Treatment-Refractory Hepatocellular Carcinoma. (PubMed, Liver Cancer)
    An expanded cohort of 19 patients with HCC who progressed on or after prior immunotherapy (primarily atezolizumab/bevacizumab) are included in this analysis. The BOT+BAL combination demonstrated durable responses and manageable safety in treatment-refractory patients with HCC previously treated with immunotherapy, supporting further investigation in randomized studies. Despite the small sample size and high percentage of patients with albumin-bilirubin grade 2 liver disease, these results provide early evidence of antitumor activity in a difficult-to-treat disease setting.
    Clinical • P1 data • Journal
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    26d
    A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=37 --> 20
    Enrollment closed • Enrollment change
    |
    paclitaxel • Cyramza (ramucirumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AgenT-797
    28d
    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)
    29d
    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)
    1m
    NUMANTIA-2: A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Nelum Corp
    New P2 trial
    |
    gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • NLM-001
    1m
    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
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    2ms
    Botensilimab, Balstilimab, and SBRT in Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Massachusetts General Hospital | Initiation date: Feb 2026 --> Jun 2026
    Trial initiation date • MSI-H • pMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial (clinicaltrials.gov)
    P2, N=16, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)