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    DRUG:

    botensilimab (AGEN1181)

    i
    Other names: AGEN1181, AGEN 1181, AGEN-1181
    Company:
    Agenus, Zydus Lifesci
    Drug class:
    CTLA4 antagonist
    Related drugs:
    6d
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P1, N=54, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Nov 2028 --> Jul 2029 | Trial primary completion date: Nov 2028 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    21d
    A Study of Botensilimab and Balstilimab for Colorectal Cancer (clinicaltrials.gov)
    P2, N=284, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Circulating tumor DNA
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    24d
    NCI-2022-09458: FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=20, Active, not recruiting, City of Hope Medical Center | Trial completion date: Oct 2025 --> Jun 2026 | Trial primary completion date: Oct 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    POLE (DNA Polymerase Epsilon)
    |
    POLE mutation
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    29d
    Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy (clinicaltrials.gov)
    P1/2, N=28, Active, not recruiting, City of Hope Medical Center | Trial primary completion date: Oct 2025 --> May 2025
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Northwell Health
    New P1 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • doxorubicin hydrochloride • irinotecan • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN2373
    3ms
    BATTMAN: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma (clinicaltrials.gov)
    P3, N=834, Not yet recruiting, Canadian Cancer Trials Group
    New P3 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    4ms
    Botensilimab, Balstilimab, and SBRT in Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Massachusetts General Hospital
    New P1 trial • MSI-H • pMMR
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    4ms
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=36, Suspended, Weill Medical College of Cornell University | Trial completion date: Dec 2025 --> Jun 2026 | Recruiting --> Suspended | Trial primary completion date: May 2025 --> Nov 2025
    Trial completion date • Trial suspension • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery (clinicaltrials.gov)
    P2, N=26, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Nov 2027 | Trial primary completion date: Dec 2026 --> Nov 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    7ms
    C-800-25: A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=234, Active, not recruiting, Agenus Inc. | Trial completion date: Jul 2025 --> Sep 2029 | Trial primary completion date: Feb 2025 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Recruiting, University of Colorado, Denver | N=28 --> 65
    Enrollment change • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    7ms
    Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Completed, Agenus Inc. | Active, not recruiting --> Completed | Trial completion date: Jan 2027 --> Dec 2024 | Trial primary completion date: Jan 2027 --> Dec 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN1571