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    DRUG CLASS:

    CTLA4 antagonist

    Related drugs:
    9d
    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
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    balstilimab (AGEN2034) • zalifrelimab (UGN-301)
    20d
    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
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    MSI-H/dMMR
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    docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    22d
    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)
    26d
    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
    Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=54, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    PD-L1 IHC 22C3 pharmDx
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
    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
    A clinical study to evaluate the safety and efficacy of Iparomlimab/Tuvonralimab injection (QL1706, a bifunctional Mabpair product of anti-PD-1 and anti-CTLA-4 antibodies) in combination with concurrent chemoradiotherapy in patients with locally advanced cervical cancer (ChiCTR2500112102)
    P=N/A, N=30, Not yet recruiting, Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital, Chinese Academy of Medical Sciences
    New trial
    |
    Qibeian (iparomlimab/tuvonralimab)
    2ms
    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 completion date: Dec 2025 --> Aug 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Stivarga (regorafenib) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas (clinicaltrials.gov)
    P2, N=65, Recruiting, University of Colorado, Denver | Trial completion date: Nov 2026 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    pegylated liposomal doxorubicin • balstilimab (AGEN2034) • botensilimab (AGEN1181) • zalifrelimab (UGN-301)
    2ms
    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 | Initiation date: Nov 2025 --> Feb 2026
    Trial initiation date
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    The Seven Trial: Exploiting the Unfolded Protein Response (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, HonorHealth Research Institute | Recruiting --> Active, not recruiting | N=18 --> 6 | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • balstilimab (AGEN2034) • botensilimab (AGEN1181) • celecoxib oral • chloroquine phosphate
    3ms
    Botensilimab (Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (anti-PD-1 antibody) in patients with treatment-refractory ovarian cancer. (PubMed, J Immunother Cancer)
    The BOT/BAL combination demonstrated deep, durable responses and complete remissions in patients with treatment-refractory ovarian cancer where no standard treatments are currently available. RECIST under-represented clinical benefit with 11 patients achieving prolonged/clinically meaningful stable disease (or better) for ≥24 weeks. Toxicities were manageable and reversible. The encouraging clinical activity of BOT/BAL in heavily pretreated patients, as well as biomarker associations, warrants further investigation of this combination.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    ITGAX (Integrin Subunit Alpha X)
    |
    PD-L1 expression
    |
    balstilimab (AGEN2034) • botensilimab (AGEN1181)