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    DRUG:

    balstilimab (AGEN2034)

    i
    Other names: AGEN-2034, RebmAb700, RebmAb 700, AGEN2034, RebmAb-700, AGEN 2034
    Company:
    Agenus, Betta Pharma, Zydus Lifesciences
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    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)
    6d
    NCI-2022-03805: BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    balstilimab (AGEN2034)
    8d
    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)
    13d
    RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer (clinicaltrials.gov)
    P2, N=211, Terminated, Agenus Inc. | Active, not recruiting --> Terminated; Sponsor strategic decision
    Trial termination
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    23d
    rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG (clinicaltrials.gov)
    P1, N=36, Recruiting, Ann & Robert H Lurie Children's Hospital of Chicago | Trial completion date: Dec 2025 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Sep 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition • First-in-human
    |
    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    28d
    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)
    1m
    NEOASIS: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations (clinicaltrials.gov)
    P2/3, N=133, Recruiting, The Netherlands Cancer Institute | N=92 --> 133
    Enrollment change • Pan tumor
    |
    MSI-H/dMMR
    |
    docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    CIME/ET23-185: Study aiming to compare the survival of patients with locally advanced or metastatic MSI/dMMR Esogastric adenocarcinomas treated by a combination of Immune checkpoint inhibitors (botensilimab + balstilimab) versus the standard of care (FOLFOX/XELOX + nivolumab) (2023-506291-28-00)
    P2/3, N=132, Recruiting, Centre Leon Berard | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • dMMR
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • MSI-H/dMMR • HER-2 negative
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    BATTMAN: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma (clinicaltrials.gov)
    P3, N=834, Recruiting, Canadian Cancer Trials Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis (clinicaltrials.gov)
    P1, N=10, Recruiting, Northwell Health | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • 5-fluorouracil • doxorubicin hydrochloride • irinotecan • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181) • AGEN2373
    2ms
    BBOpCo: Botensilimab and Balstilimab Optimization in Colorectal Cancer (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Nicholas DeVito, MD | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    ARCITECT: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (clinicaltrials.gov)
    P2, N=120, Suspended, Michael B. Atkins, MD | Trial completion date: Oct 2026 --> Nov 2027 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Nov 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)