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    DRUG:

    balstilimab (AGEN2034)

    i
    Other names: AGEN2034, RebmAb-700, AGEN 2034, AGEN-2034, RebmAb700, RebmAb 700
    Company:
    Agenus, Betta Pharma, Zydus Lifesci
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    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)
    6d
    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)
    7d
    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)
    21d
    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)
    22d
    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
    1m
    ARCITECT: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (clinicaltrials.gov)
    P2, N=120, Recruiting, Michael B. Atkins, MD | Trial primary completion date: Oct 2025 --> Jan 2026
    Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    1m
    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)
    2ms
    CIME: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas (clinicaltrials.gov)
    P3, N=132, Recruiting, Centre Leon Berard | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • dMMR
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • balstilimab (AGEN2034) • botensilimab (AGEN1181)
    2ms
    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)
    3ms
    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)
    3ms
    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
    3ms
    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)