2025
Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers
Champiat S, Garralda E, Galvao V, Cassier P, Gomez-Roca C, Korakis I, Grell P, Naing A, LoRusso P, Mikyskova R, Podzimkova N, Reinis M, Ouali K, Schoenenberger A, Kiemle-Kallee J, Tillmanns S, Sachse R, Moebius U, Spisek R, Bechard D, Jelinkova L, Adkins I, Marabelle A. Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. Cell Reports Medicine 2025, 6: 101967. PMID: 39933529, PMCID: PMC11866505, DOI: 10.1016/j.xcrm.2025.101967.Peer-Reviewed Original ResearchConceptsCD8<sup>+</sup> T cellsNatural killerT cellsAnti-programmed cell death protein 1Frequent treatment-emergent adverse eventsProportion of CD8<sup>+</sup> T cellsAnti-PD-1 pembrolizumabTreatment-emergent adverse eventsCell death protein 1Anti-PD-1Advanced/metastatic solid tumorsStimulated natural killerInjection site reactionsIL-15 receptorMouse tumor modelsPD-1NK cellsPeripheral bloodIL-15Safety profileSite reactionsSolid tumorsClinical efficacyAdverse eventsTumor model
2024
996MO Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced/metastatic solid tumors: Data from phase I dose escalation
Luke J, Gao X, Olszanski A, Sanborn R, Falchook G, Patel S, Bedard P, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Ramesh R, Xu R, Wu B, Ding K, Raizer J, Lorusso P. 996MO Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced/metastatic solid tumors: Data from phase I dose escalation. Annals Of Oncology 2024, 35: s678-s679. DOI: 10.1016/j.annonc.2024.08.1055.Peer-Reviewed Original ResearchAFNT-211: A phase 1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR, a CD8α/β coreceptor, and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors.
Mitchell S, Khan B, Payumo F, Chiorean E, Gahvari Z, Hecht J, Hurwitz M, Leidner R, Lenz H, Pelster M, Punekar S, Schoenfeld A, Zhao D, Vallaster M, Nagorsen D. AFNT-211: A phase 1 study of autologous CD4+ and CD8+ T cells engineered to express a high avidity HLA-A*11:01-restricted, KRAS G12V-specific, transgenic TCR, a CD8α/β coreceptor, and a FAS41BB switch receptor in patients with advanced/metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps8650-tps8650. DOI: 10.1200/jco.2024.42.16_suppl.tps8650.Peer-Reviewed Original ResearchOptimal biological doseCD8+ T cellsAutologous CD4+Advanced/metastatic solid tumorsT cellsSolid tumorsSwitch receptorsDose expansionDose escalationCD4+Transgenic TCRMechanism of actionDose-limiting toxicity observation periodRecommended phase 2 doseT cell cytotoxic activityIncreased T cell activationCD4+ T cellsHelper T cell responsesPreventing T cell exhaustionPost-treatment follow-up periodChimeric switch receptorsPhase 2 doseImmunosuppressive tumor microenvironmentT cell exhaustionDuration of responsePhase 1 study of AM003, a novel individualized immunotherapy, in a basket of advanced solid tumors.
Carmi Levy I, Amitzi L, Lavi E, Zilony - Hanin N, Pode Z, Berger R, Smith K. Phase 1 study of AM003, a novel individualized immunotherapy, in a basket of advanced solid tumors. Journal Of Clinical Oncology 2024, 42: tps2692-tps2692. DOI: 10.1200/jco.2024.42.16_suppl.tps2692.Peer-Reviewed Original ResearchSolid tumorsIndividualized immunotherapyClinical benefitTumor cellsFirst-in-human phase 1Preliminary evidence of clinical benefitEvidence of clinical benefitImmune-oncology agentsDose-escalation partAdvanced solid tumorsDose-escalation studyRelapsed/refractory solid tumorsAdvanced/metastatic solid tumorsTumor cell lysisPatient tumor cellsPhase 1 studyImmune T cellsAntigen presenting cellsFirst-in-humanStimulate antigen presenting cellsIdentification of biomarkersCTCAE v5Dose expansionIT injectionSystemic therapyEfficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.
Macarulla T, Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2024, 42: 487-487. DOI: 10.1200/jco.2024.42.3_suppl.487.Peer-Reviewed Original ResearchBiliary tract cancerTreatment-related AEsAdvanced biliary tract cancerMonotherapy trialsStable diseasePartial responseCombination trialsMouse double minute 2MDM2-p53 antagonistsEscalating dosesSolid tumorsCases of biliary tract cancerTP53 wild-type tumorsAnti-PD-1 antibodyStandard-of-care chemotherapyData cut-offWild-type tumorsAdvanced/metastatic solid tumorsResponding ptsMDM2-p53MDM2 amplified tumorsDouble minute 2MDM2-amplifiedAmpullary adenocarcinomaCell cycle arrest
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