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    DRUG:

    Zynyz (retifanlimab-dlwr)

    i
    Other names: INCMGA0012, MGA 012, MGA012, ZL1306, MGA-012, NCMGA-0012, INCMGA 0012 , INCMGA00012, ZL-1306, ZL 1306
    Company:
    Incyte, Knight Therap, MacroGenics, Sagard Healthcare
    Drug class:
    PD1 inhibitor
    Related drugs:
    11d
    BRIA-ABC: Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Completed, BriaCell Therapeutics Corporation | Enrolling by invitation --> Completed | Trial completion date: Nov 2028 --> Mar 2026 | Trial primary completion date: Nov 2025 --> Mar 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    14d
    A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=9, Active, not recruiting, Incyte Corporation | Trial completion date: Oct 2028 --> May 2026 | Trial primary completion date: Oct 2028 --> May 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr)
    22d
    ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (clinicaltrials.gov)
    P1/2, N=31, Not yet recruiting, University of Wisconsin, Madison
    New P1/2 trial
    |
    Inqovi (decitabine/cedazuridine) • Zynyz (retifanlimab-dlwr)
    27d
    Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas (clinicaltrials.gov)
    P1/2, N=33, Not yet recruiting, Mayo Clinic
    New P1/2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH wild-type
    |
    Zynyz (retifanlimab-dlwr)
    28d
    Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | Trial completion date: Jan 2030 --> Mar 2029 | Trial primary completion date: Apr 2027 --> Apr 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH2 mutation • MGMT promoter methylation • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • neoantigen DNA vaccine
    2ms
    HPV ctDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Advanced-Stage Anal Cancer (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Jennifer Dorth
    New P2 trial • Circulating tumor DNA
    |
    IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • DPYD (Dihydropyrimidine Dehydrogenase)
    |
    capecitabine • Zynyz (retifanlimab-dlwr)
    2ms
    Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) (clinicaltrials.gov)
    P1/2, N=2, Terminated, Ariceum Therapeutics GmbH | N=50 --> 2 | Trial completion date: Dec 2026 --> Dec 2025 | Recruiting --> Terminated | Trial primary completion date: Aug 2026 --> Dec 2025; Study terminated due to strategic business decisions.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr) • SOMther (lutetium-177 DOTA satoreotide)
    2ms
    All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma (clinicaltrials.gov)
    P2, N=55, Recruiting, Stephen Bagley, MD, MSCE | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH1 mutation • IDH2 mutation
    |
    Zynyz (retifanlimab-dlwr)
    3ms
    MERCURY: Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • etoposide IV • Zynyz (retifanlimab-dlwr)
    3ms
    PRISM: Retifanlimab and Ruxolitinib In Solid Malignancies (clinicaltrials.gov)
    P1/2, N=40, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
    3ms
    Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma (clinicaltrials.gov)
    P1, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jan 2027 --> Jan 2029 | Trial primary completion date: Jan 2026 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    temozolomide • carmustine • Zynyz (retifanlimab-dlwr)
    3ms
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jan 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)