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    DRUG:

    botensilimab (AGEN1181)

    i
    Company:
    Agenus
    Drug class:
    CTLA4 antagonist
    Related drugs:
    6d
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=174, Active, not recruiting, Agenus Inc. | Trial completion date: May 2028 --> Feb 2028 | Trial primary completion date: May 2028 --> Feb 2028
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    18d
    A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma (clinicaltrials.gov)
    P2, N=40, Recruiting, Memorial Sloan Kettering Cancer Center
    New P2 trial • Mismatch repair
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    26d
    A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=81, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • botensilimab (AGEN1181)
    26d
    Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) (clinicaltrials.gov)
    P2, N=112, Recruiting, Gruppo Oncologico del Nord-Ovest | Trial primary completion date: May 2025 --> May 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • 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 • POLE mutation • KRAS wild-type • RAS wild-type • KRAS G12 • POLD1 mutation • HER-2 positive + HER-2 overexpression • HER-2 positive + RAS wild-type
    |
    Imfinzi (durvalumab) • Vectibix (panitumumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    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 | Recruiting --> Active, not recruiting | N=86 --> 20
    Enrollment closed • Enrollment change
    |
    POLE (DNA Polymerase Epsilon)
    |
    POLE mutation
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    1m
    C-800-01: Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer (clinicaltrials.gov)
    P1, N=499, Active, not recruiting, Agenus Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Jan 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients with KRAS-Mutant Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, University of Southern California | Not yet recruiting --> Recruiting | Trial completion date: Oct 2027 --> Jan 2028 | Initiation date: Oct 2024 --> Jan 2025 | Trial primary completion date: Oct 2026 --> Jan 2027
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Botensilimab (Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti-PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas. (PubMed, J Clin Oncol)
    The combination of BOT/BAL demonstrated promising efficacy and safety in a large cohort of heavily pretreated sarcoma patients. This encouraging activity warrants further investigation (ClinicalTrials.gov identifier: NCT03860272).
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, City of Hope Medical Center
    New P2 trial
    |
    capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    2ms
    The Seven Trial: Exploiting the Unfolded Protein Response (clinicaltrials.gov)
    P1, N=18, Recruiting, HonorHealth Research Institute | Not yet recruiting --> Recruiting | N=12 --> 18
    Enrollment open • Enrollment change
    |
    HSPA5 (Heat Shock Protein Family A (Hsp70) Member 5)
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • celecoxib oral • chloroquine phosphate
    2ms
    C-1100-01: Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=91, Completed, Agenus Inc. | Active, not recruiting --> Completed | N=67 --> 91 | Trial completion date: Jun 2027 --> Nov 2024 | Trial primary completion date: Jun 2025 --> Feb 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    botensilimab (AGEN1181) • AGEN2373
    2ms
    Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval (clinicaltrials.gov)
    P=N/A, N=0, Available, Agenus Inc.
    New trial
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    Phase 2 Study of SR-8541A in Combination with Botensilimab and Balstilimab in Subjects with Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) (clinicaltrials.gov)
    P2, N=70, Recruiting, Stingray Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma (clinicaltrials.gov)
    P2, N=220, Active, not recruiting, Agenus Inc. | Suspended --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    3ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=28, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    4ms
    Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, City of Hope Medical Center | N=84 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Metastases
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    5ms
    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, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1
    Enrollment open • Phase classification • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    6ms
    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 | Recruiting --> Active, not recruiting | N=63 --> 28
    Enrollment closed • Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    6ms
    Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Stingray Therapeutics
    New P2 trial • Combination therapy • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    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 | Trial completion date: Jul 2027 --> Oct 2027 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2026 --> Oct 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    C-800-01: Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer (clinicaltrials.gov)
    P1, N=550, Recruiting, Agenus Inc.
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, City of Hope Medical Center
    New P2 trial • Metastases
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    7ms
    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 | Initiation date: May 2024 --> Oct 2024
    Trial initiation date • Checkpoint inhibition • Tumor mutational burden • IO biomarker • Metastases
    |
    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)
    7ms
    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 | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    POLE (DNA Polymerase Epsilon)
    |
    Avastin (bevacizumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • fluorouracil topical
    7ms
    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 | Trial completion date: Nov 2024 --> Oct 2025 | Trial primary completion date: Nov 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    8ms
    Fc-enhanced anti-CTLA-4, anti-PD-1, doxorubicin, and ultrasound-mediated BBB opening: A novel combinatorial immunotherapy regimen for gliomas. (PubMed, Neuro Oncol)
    Our findings demonstrate that FcE-aCTLA-4 promotes robust immunomodulatory and anti-tumor effects in murine gliomas and is significantly enhanced when combined with anti-PD-1, doxorubicin, and LIPU/MB. We are currently investigating this combinatory strategy in a clinical trial (clinicaltrials.gov NCT05864534).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    doxorubicin hydrochloride • botensilimab (AGEN1181)
    9ms
    Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial. (PubMed, Nat Med)
    The combination of BOT plus BAL demonstrated a manageable safety profile with no new immune-mediated safety signals and encouraging clinical activity with durable responses. ClinicalTrials.gov identifier: NCT03860272 .
    P1 data • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    9ms
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1 --> P2
    Phase classification • Metastases
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    10ms
    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, Recruiting, Immune Oncology Research Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    10ms
    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 | Trial completion date: Apr 2027 --> Jul 2027 | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Apr 2026 --> Jul 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    10ms
    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)
    11ms
    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
    11ms
    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)
    12ms
    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)
    12ms
    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
    12ms
    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)
    12ms
    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)
    12ms
    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)
    12ms
    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)
    1year
    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)
    1year
    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)
    1year
    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)