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    DRUG:

    botensilimab (AGEN1181)

    i
    Other names: AGEN1181, AGEN 1181
    Company:
    Agenus
    Drug class:
    CTLA4 antagonist
    Related drugs:
    1d
    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=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P1 trial • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    21d
    Study of AGEN1571 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=98 --> 22
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN1571
    28d
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Weill Medical College of Cornell University | Active, not recruiting --> Recruiting | N=12 --> 36 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: May 2024 --> May 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    CIME: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas (clinicaltrials.gov)
    P3, N=124, Not yet recruiting, Centre Leon Berard
    New P3 trial
    |
    TMB (Tumor Mutational Burden) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=67, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | N=200 --> 67
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    botensilimab (AGEN1181) • AGEN2373
    2ms
    Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, University of Southern California
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD8 (cluster of differentiation 8)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    2ms
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=230, Active, not recruiting, Agenus Inc. | Trial primary completion date: Jan 2024 --> Feb 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    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)
    2ms
    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, Not yet recruiting, Immune Oncology Research Institute
    New P2 trial • Combination therapy
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Weill Medical College of Cornell University
    New P2 trial
    |
    CD8 (cluster of differentiation 8)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • dalutrafusp alfa (AGEN1423)
    3ms
    NEOASIS: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations (clinicaltrials.gov)
    P2/3, N=92, Recruiting, The Netherlands Cancer Institute
    New P2/3 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Nicholas DeVito, MD
    New P2 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    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=38, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Combination therapy • Metastases
    |
    paclitaxel • Cyramza (ramucirumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AgenT-797
    4ms
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=220, Suspended, Agenus Inc. | Trial completion date: Oct 2023 --> May 2028 | Recruiting --> Suspended | Trial primary completion date: Oct 2023 --> May 2028
    Trial completion date • Trial suspension • Trial primary completion date • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    5ms
    Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Northwestern University | Not yet recruiting --> Recruiting
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    5ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    doxorubicin hydrochloride • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    5ms
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=230, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    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)
    5ms
    NEST-1: Combination Immunotherapy in Colorectal Cancer (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Northwestern University | Phase classification: P=N/A --> P2
    Phase classification • Trial initiation date • Combination therapy
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    Next-generation CTLA-4 targeting molecules and combination therapy: promising strategies for improving cancer immunotherapy. (PubMed, Oncoimmunology)
    Next-generation anti-CTLA-4 antibodies, such as botensilimab, are showing promise in clinical trials. Combining botensilimab with RT and/or CD40 agonist may offer additional benefits for challenging tumor types.
    Journal • Combination therapy
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD40 (CD40 Molecule)
    |
    botensilimab (AGEN1181)
    7ms
    ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    New P1 trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    The Seven Trial: Exploiting the Unfolded Protein Response (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, HonorHealth Research Institute
    New P1 trial • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • celecoxib oral
    9ms
    ARCITECT: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (clinicaltrials.gov)
    P2, N=120, Recruiting, Michael B. Atkins, MD | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    10ms
    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=63, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    11ms
    ARCITECT: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Michael B. Atkins, MD
    New P2 trial • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    11ms
    Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (clinicaltrials.gov)
    P2, N=98, Recruiting, Gruppo Oncologico del Nord-Ovest | Active, not recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • CD8 (cluster of differentiation 8) • POLD1 (DNA Polymerase Delta 1) • CD4 (CD4 Molecule)
    |
    HER-2 positive • MSI-H/dMMR • HER-2 amplification • POLE mutation • POLD1 mutation • POLE mutation + POLD1 mutation
    |
    Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1year
    Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (clinicaltrials.gov)
    P2, N=98, Active, not recruiting, Gruppo Oncologico del Nord-Ovest
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • CD8 (cluster of differentiation 8) • POLD1 (DNA Polymerase Delta 1) • CD4 (CD4 Molecule)
    |
    HER-2 positive • MSI-H/dMMR • HER-2 amplification • POLE mutation • POLD1 mutation • POLE mutation + POLD1 mutation
    |
    Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1year
    Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer (clinicaltrials.gov)
    P1, N=450, Recruiting, Agenus Inc. | N=195 --> 450
    Enrollment change • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1year
    Treatment with doxorubicin and PD-1/CTLA-4 blockade improves T cell activation and anti-tumor efficacy in MCA-205 murine fibrosarcoma (P472) (IMMUNOLOGY 2023)
    MCA-205 tumors were generated in C57BL/6 mice and were treated with DOX, anti-PD1 (RMP1-14), anti-CTLA4 (9D9 mouse IgG2b) or a mouse surrogate of botensilimab, an anti-CTLA4 (9D9 mouse IgG2b.DLE) antibody with enhanced binding to FcγR, or combination DOX plus anti-PD-1/CTLA-4. Pathway analysis from bulk RNA sequencing demonstrated upregulation of T cell activation in DOX/PD-1/CTLA-4 tumors compared to control tumors. Further work will correlate these findings with human STS patients receiving DOX plus CTLA-4/PD-1 blockade in an ongoing clinical trial (NCT04028063).
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule)
    |
    doxorubicin hydrochloride • botensilimab (AGEN1181)
    1year
    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=86, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023
    Enrollment open • Trial initiation date • Combination therapy • Metastases
    |
    POLE (DNA Polymerase Epsilon)
    |
    POLE mutation
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    1year
    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=63, Not yet recruiting, City of Hope Medical Center | Initiation date: Mar 2023 --> Jun 2023
    Trial initiation date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    over1year
    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=63, Not yet recruiting, City of Hope Medical Center
    New P1/2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=78, Recruiting, Agenus Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=200, Recruiting, Agenus Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=230, Recruiting, Agenus Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=230, Not yet recruiting, Agenus Inc. | N=120 --> 230
    Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=78, Not yet recruiting, Agenus Inc.
    New P2 trial • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • botensilimab (AGEN1181)
    over1year
    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=86, Not yet recruiting, City of Hope Medical Center
    New P1/2 trial • Combination therapy • Metastases
    |
    POLE (DNA Polymerase Epsilon)
    |
    POLE mutation
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    over1year
    A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Agenus Inc.
    New P2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Agenus Inc. | N=120 --> 200
    Enrollment change • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    botensilimab (AGEN1181)
    over1year
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Agenus Inc.
    New P2 trial • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    botensilimab (AGEN1181)
    over2years
    Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patient With Advanced Cancer (clinicaltrials.gov)
    P1, N=200, Recruiting, Agenus Inc. | N=86 --> 200 | Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Sep 2023 --> Jun 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    botensilimab (AGEN1181) • AGEN2373