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    DRUG CLASS:

    CD28 agonist

    Related drugs:
    1m
    Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=66, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    capecitabine • oxaliplatin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1m
    EMPIRE (NSABP FC-13): a biomarker-driven phase II platform trial evaluating cemiplimab-based immunotherapy in microsatellite-stable colorectal cancer with ctDNA-defined minimal residual disease. (PubMed, Future Oncol)
    Eligible patients have postoperative ctDNA positivity in the absence of radiographic recurrence and are allocated to one of three treatment arms: cemiplimab monotherapy; cemiplimab plus fianlimab (a lymphocyte activation gene-3 inhibitor); or cemiplimab plus REGN7075 (an EGFR×CD28 costimulatory bispecific antibody). Arms 2 and 3 use single-stage phase II designs, whereas Arm 1 follows a Simon two-stage design with early futility stopping. The study integrates comprehensive correlative analyses to characterize mechanisms of response and resistance.Clinical trial registration: The http://www.clinicaltrials.gov identifier is NCT07058012.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Minimal residual disease • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor) • LAG3 (Lymphocyte Activating 3)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    RNDO-564-001: Phase 1/1b Study of RNDO-564 in Participants with Advanced Urothelial Cancer (2025-524687-38-00)
    P1, N=34, Not yet recruiting, Rondo Therapeutics Inc.
    New P1 trial
    2ms
    Multiple Myeloma Cells Resistant to T-cell Therapies Exhibits a CD45+ Immune Evasive Phenotype. (PubMed, Cancer Immunol Res)
    Bone marrow samples were treated ex vivo with BCMA CAR T cells, TCEs (elranatamab, SAR442257), or activated T cells, and analyzed by flow cytometry. CD45 upregulation was validated in patient samples before and after idecabtagene vicleucel therapy (anti-BCMA CAR T-cell therapy), and by using in an in vivo mouse model of disseminated MM...Mechanistic studies implicated secreted HSP70, while bulk RNA-sequencing revealed increased LAG-3, IFN-γ signaling, and PD-L1 expression. These findings suggest T cell-redirecting therapy (TCRT) drives an immuno-evasive phenotype defined by CD45 upregulation and immune checkpoint activation, supporting combination strategies of TCRT with checkpoint inhibitors to overcome resistance in relapsed/refractory MM.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    PD-L1 expression
    |
    Elrexfio (elranatamab-bcmm) • SAR442257 • Abecma (idecabtagene vicleucel)
    2ms
    First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL (clinicaltrials.gov)
    P1, N=47, Completed, Sanofi | Active, not recruiting --> Completed
    Trial completion • First-in-human
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    SAR442257
    3ms
    MDX-2001-101: Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=285, Recruiting, ModeX Therapeutics, An OPKO Health Company | N=115 --> 285
    Enrollment change • First-in-human
    3ms
    A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=228, Recruiting, Regeneron Pharmaceuticals | N=370 --> 228 | Trial completion date: Jan 2027 --> Mar 2030 | Trial primary completion date: Jan 2027 --> Mar 2030
    Enrollment change • Trial completion date • Trial primary completion date
    |
    nezastomig (REGN5678)
    3ms
    ATHENA-1: A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=107, Recruiting, Regeneron Pharmaceuticals | Trial completion date: May 2029 --> Jan 2030 | Trial primary completion date: Jun 2027 --> Feb 2029
    Trial completion date • Trial primary completion date
    |
    Ordspono (odronextamab) • REGN5837
    3ms
    A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=355, Recruiting, Janssen Research & Development, LLC | N=250 --> 355
    Enrollment change
    |
    apalutamide • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • JNJ-6143 • pasritamig (JNJ-8343)
    3ms
    A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC (clinicaltrials.gov)
    P1, N=138, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • First-in-human
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    3ms
    Study of ZGGS34 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • MSI (Microsatellite instability) • MUC17 (Mucin 17)
    |
    MSI-H/dMMR
    |
    alveltamig (ZG006)
    3ms
    R17372-HM-2493: A Trial to Study if REGN17372 in Combination with Linvoseltamab is Tolerable for Adult Participants with Relapsed/Refractory Multiple Myeloma (2025-522776-93-00)
    P1, N=26, Not yet recruiting, Regeneron Pharmaceuticals Inc.
    New P1 trial • First-in-human
    |
    Lynozyfic (linvoseltamab-gcpt)