^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    botensilimab (AGEN1181)

    i
    Other names: AGEN1181, AGEN 1181, AGEN-1181
    Company:
    Agenus, Zydus Lifesciences
    Drug class:
    CTLA4 antagonist
    Related drugs:
    17h
    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)
    3d
    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
    5d
    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)
    5d
    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)
    7d
    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
    21d
    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)
    28d
    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)
    1m
    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)
    1m
    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)
    2ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Recruiting, Weill Medical College of Cornell University | Trial completion date: Mar 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    2ms
    Molecular complete response to the RIN protocol (regorafenib, ipilimumab, and nivolumab) in a patient with advanced recurrent metastatic mismatch repair proficient/microsatellite stable (pMMR/MSS) rectal cancer. (PubMed, Ther Adv Med Oncol)
    Rectal cancer recurrence remains a major therapeutic challenge, particularly in patients unresponsive to conventional regimens. While previous studies have demonstrated limited benefit of immunotherapy in this tumor subtype, the present findings suggest an emerging therapeutic opportunity that warrants prospective evaluation to confirm efficacy, explore the mechanistic basis, and identify biomarkers predictive of durable response beyond the absence of liver metastases. More effective combinatorial regimens like zanzalintinib and atezolizumb (STELLAR-303) trial, as well as newer generation of CTLA-4 inhibitors like botensilimab, vilastobart, and muzastotug are showing more promise for patients with MSS colorectal cancers in particular who do not have liver metastases (NLM).
    Journal • Mismatch repair • PD(L)-1 Biomarker • IO biomarker • pMMR
    |
    KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Stivarga (regorafenib) • botensilimab (AGEN1181) • vilastobart (XTX101) • muzastotug (ADG126) • zanzalintinib (XL092)
    2ms
    Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (clinicaltrials.gov)
    P2, N=197, Recruiting, Gruppo Oncologico del Nord-Ovest | N=140 --> 197
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • POLD1 (DNA Polymerase Delta 1)
    |
    HER-2 positive • MSI-H/dMMR • KRAS G12C • HER-2 amplification • HER-2 mutation • MET amplification • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
    |
    Opdivo (nivolumab) • Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • vorbipiprant (CR6086)