2025
A phase 1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia.
Roeland E, Tejani M, Cheung E, Dincman T, Lohiya V, Agarwal R, Sajid S, Gabayan A, Thumar J, Jin B, Lebedinsky C, Braendle E, Zuniga R. A phase 1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps12142.Peer-Reviewed Original ResearchGDF-15Multicenter phase 1b studyStandard-of-care therapyProportion to disease severityEscalating dose cohortsDose-limiting toxicityPhase 1b studyDose-escalation studyPathogenesis of cachexiaGDF-15 expressionRisk of side effectsAnti-drug antibodiesHigher risk of deathOff-label treatmentFDA-approved therapiesTreating cancer cachexiaAnimal cancer modelsPhase 1 healthy volunteer studyCirculating GDF-15Body weight regulationReverse weight lossRisk of deathYears of ageIgG1 monoclonal antibodyPatient-reported outcomesDevelopment of Rifampicin Eye Drops for the Treatment of Exudative Age-Related Macular Degeneration
Vailoces V, Tolentino A, Arevalo J, Adelman R, Bhisitkul R, V. D, Nguyen Q, Tolentino M, Tanito M, Serizawa H. Development of Rifampicin Eye Drops for the Treatment of Exudative Age-Related Macular Degeneration. Pharmaceuticals 2025, 18: 655. PMID: 40430474, PMCID: PMC12115180, DOI: 10.3390/ph18050655.Peer-Reviewed Original ResearchExudative age-related macular degenerationAge-related macular degenerationOxygen-induced retinopathyChoroidal neovascularizationMacular degenerationTopical applicationEffective doseTreatment of exudative age-related macular degenerationMouse laser-induced choroidal neovascularizationMouse laser-induced CNV modelTreatment of exudative macular degenerationInhibit neovascularizationRat oxygen-induced retinopathyLaser-induced choroidal neovascularizationLaser-induced CNV modelExudative macular degenerationDose-escalation studyPrevent vision lossDoses of rifampicinInhibition of neovascularizationConcentration-time curveAdministration of rifampicinAnti-angiogenesis effectDose-dependent mannerAnti-angiogenic propertiesA Phase 1/1B Trial of Pembrolizumab and Trametinib in Advanced NSCLC Enriched for KRAS Mutations
Riess J, Lara M, Luxardi G, de Rodas M, Shimoda M, Kelly K, Lara P, Beckett L, Monjazeb A, Schalper K, Maverakis E, Gandara D. A Phase 1/1B Trial of Pembrolizumab and Trametinib in Advanced NSCLC Enriched for KRAS Mutations. JTO Clinical And Research Reports 2025, 6: 100806. PMID: 40486486, PMCID: PMC12145753, DOI: 10.1016/j.jtocrr.2025.100806.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerMEK inhibitionAdverse eventsProgressive diseaseKRAS mutationsMyeloid-derived suppressor cellsTrametinib 2 mgDose-escalation studyPlatinum-based chemotherapyImmune cell alterationsTumor immune microenvironmentPhase 1 studyCell lung cancerHigh-parameter flow cytometryArm BEscalation studyPartial responseArm ASuppressor cellsImmune microenvironmentPembrolizumabTrametinibQuantitative immunofluorescenceLung cancerDose finding study of CBM588 in combination with nivolumab and ipilimumab in patients with metastatic renal cell carcinoma: A phase I study.
Agarwal R, Ebrahimi H, Zengin Z, Barragán Carrillo R, Dizman N, Zugman M, Jaime-Casas S, Meza L, Li X, Hsu J, Castro D, Mercier B, Lee P, Takahashi M, Tripathi A, Dorff T, Caporaso G, Lee K, Pal S, Chehrazi-Raffle A. Dose finding study of CBM588 in combination with nivolumab and ipilimumab in patients with metastatic renal cell carcinoma: A phase I study. Journal Of Clinical Oncology 2025, 43: tps611-tps611. DOI: 10.1200/jco.2025.43.5_suppl.tps611.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaImmune checkpoint inhibitorsProgression-free survivalMaximum tolerated dosePhase I studyRenal cell carcinomaDose levelsCell carcinomaClinical outcomesEfficacy of immune checkpoint inhibitorsMetastatic renal cell carcinoma patientsModulation of immune pathwaysImmune checkpoint inhibitor therapyStandard-of-care treatmentIMDC risk groupsPlanned dose levelsCombination of nivolumabDose-limiting toxicityDose-escalation designDose-escalation studyECOG performance statusDose-finding studyGut microbiomeCheckpoint inhibitorsDose escalation
2024
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study
Iyer S, Sica R, Ho P, Prica A, Zain J, Foss F, Hu B, Beitinjaneh A, Weng W, Kim Y, Khodadoust M, Huen A, Williams L, Ma A, Huang E, Ganpule A, Nagar S, Sripakdeevong P, Cullingford E, Karnik S, Dequeant M, Patel J, He X, Li Z, He Q, Mendonez J, Keegan A, Horwitz S. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. The Lancet Oncology 2024, 26: 110-122. PMID: 39617017, DOI: 10.1016/s1470-2045(24)00508-4.Peer-Reviewed Original ResearchT-cell lymphomaPeripheral T-cell lymphomaCutaneous T-cell lymphomaRefractory T-cell lymphomaEastern Cooperative Oncology GroupChimeric antigen receptorCytokine release syndromeCAR+ T cellsSerious adverse eventsAdverse eventsT cellsOpen-labelRefractory peripheral T-cell lymphomaAllogeneic chimeric antigen receptorHealthy donor T cellsRefractory T-cell malignanciesCAR-T cell therapyMedian patient follow-upIncidence of adverse eventsDonor T cellsObjective response rateSystemic therapy linesDose-limiting toxicityT-cell therapyDose-escalation study990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors
Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Friedman I, Hakim M, Ziv D, Hashmueli S, Mandel I, Moshe T, Crawford N, Abbadessa G, Perez R, Wu M, Borad M. 990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s675. DOI: 10.1016/j.annonc.2024.08.1049.Peer-Reviewed Original ResearchA phase (Ph) 0/Ia study of brigimadlin concentration in brain tissue and a non-randomized, open-label, dose escalation study of brigimadlin in combination with radiotherapy (RT) in patients (pts) with newly diagnosed glioblastoma (GBM).
Sarkaria J, Mrugala M, Jaeckle K, Burns T, Vaubel R, Parney I, Chaichana K, Clement P, Martinez-Garcia M, Sepulveda Sanchez J, Omuro A, Pronk L, Ross H, Teufel M, Hesse R, Grempler R, Galanis E. A phase (Ph) 0/Ia study of brigimadlin concentration in brain tissue and a non-randomized, open-label, dose escalation study of brigimadlin in combination with radiotherapy (RT) in patients (pts) with newly diagnosed glioblastoma (GBM). Journal Of Clinical Oncology 2024, 42: 2017-2017. DOI: 10.1200/jco.2024.42.16_suppl.2017.Peer-Reviewed Original ResearchNon-contrast-enhancedOpen-labelContrast enhancementMGMT promoter unmethylated glioblastomaUnbound concentrationsCalculated unbound concentrationsNewly diagnosed GBMDose-escalation studyMaximum tolerated doseTumor cell apoptosisSingle-arm trialMDM2-p53 antagonistsRestore wild-typeBrain tissueUnmethylated glioblastomaBrain tumor tissueEscalation studyDiagnosed glioblastomaTolerated doseP53 target gene expressionPrimary endpointIDH-wtSolid tumorsTumor tissuesXenograft modelA first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.
Weiss D, Dinardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Carraway H, Frankel S, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. Journal Of Clinical Oncology 2024, 42: tps6590-tps6590. DOI: 10.1200/jco.2024.42.16_suppl.tps6590.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupCell line-derived xenograftsDose-escalation studyMaximum tolerated dosePatient-derived xenograftsHigh riskEscalation studyTreatment armsEffects of CYP3A4 inhibitionRecommended phase 2 doseRelapsed/Refractory Acute Myeloid LeukemiaPhase 2 doseAccelerated titration designMinichromosome maintenance protein 2Preliminary antitumor activityCooperative Oncology GroupFirst-in-humanAcute myeloid leukemiaGrade 2 eventsTreated patient populationTolerated dose levelsAML cell linesAnti-tumor activityInhibition of Cdc7Cancer cell deathPhase 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 therapyPhase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure
Spreafico A, Couselo E, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane I, Sanmamed M, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umaña P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack R, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Frontiers In Oncology 2024, 14: 1346502. PMID: 38577337, PMCID: PMC10991832, DOI: 10.3389/fonc.2024.1346502.Peer-Reviewed Original ResearchTreatment-related adverse eventsAnti-drug antibodiesCytokine release syndromeFirst-in-humanT-cell engagersCheckpoint inhibitorsMetastatic melanomaT cellsDrug exposureDevelopment of anti-drug antibodiesActive drugImmune responseFirst-in-human studyDrug activity in vitroDose-escalation studyDose-escalation trialTumor necrosis factor-alphaB cell interactionsImpact of immune responsesActive drug exposureNecrosis factor-alphaAnti-tumor activityLoss of efficacyAssociated with developmentDose escalationThe HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results
Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.Peer-Reviewed Original ResearchConceptsHER2 antibody-drug conjugatesAntibody-drug conjugatesMetastatic breast cancerPhase 1 trialBreast cancerHER2-positive metastatic breast cancerHER2-positive breast cancerObjective response rateDose-escalation studyDuration of responseModel of HER2Anti-tumor activityMechanism of actionTrastuzumab deruxtecanPulmonary toxicityTrastuzumab emtansinePreclinical characterizationResponse rateHigh dosesVivo efficacySecondary objectiveEarly signsPotent cytotoxic agentCytotoxic agentsCancer
2023
A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
DiNardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Frankel S, Weiss D, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. Blood 2023, 142: 1548. DOI: 10.1182/blood-2023-186036.Peer-Reviewed Original ResearchR AMLAcute myeloid leukemiaRefractory acute myeloid leukemiaCell line-derived xenograftsDose-escalation studyMyelodysplastic syndromeCentral nervous systemDose levelsEscalation studyFirst doseTreatment armsMyeloid leukemiaEastern Cooperative Oncology Group performance statusRelapsed/Refractory Acute Myeloid LeukemiaPatient-derived xenograft AML modelHigh-risk myelodysplastic syndromeHigh unmet medical needAnimal models representativeMultiple prior linesPhase 2 doseSingle-patient cohortsTreatment arm ATreatment arm B.Antitumor activitySingle-dose pharmacokinetics736 A phase 1/2 open-label, dose-escalation study of ST-067, a decoy-resistant IL-18 cytokine, given as a monotherapy and with pembrolizumab in advanced solid tumor malignancies
Moser J, Sullivan R, Taylor M, Puzanov I, Falchook G, Sznol M, Paton V, Chonzi D, Garofalo B, Sonnemann M, Uppal H, Barton J, McQueen B, Ring A, Kluger H. 736 A phase 1/2 open-label, dose-escalation study of ST-067, a decoy-resistant IL-18 cytokine, given as a monotherapy and with pembrolizumab in advanced solid tumor malignancies. 2023, a829-a829. DOI: 10.1136/jitc-2023-sitc2023.0736.Peer-Reviewed Original ResearchBlinatumomab in Combination with Immune Checkpoint Inhibitors (ICIs) of PD-1 and CTLA-4 in Adult Patients with Relapsed/Refractory (R/R) CD19 Positive B-Cell Acute Lymphoblastic Leukemia (ALL): Results of a Phase I Study
Webster J, Luskin M, Rimando J, Blackford A, Zeidan A, Sharon E, Streicher H, DeAngelo D, Luznik L, Gojo I. Blinatumomab in Combination with Immune Checkpoint Inhibitors (ICIs) of PD-1 and CTLA-4 in Adult Patients with Relapsed/Refractory (R/R) CD19 Positive B-Cell Acute Lymphoblastic Leukemia (ALL): Results of a Phase I Study. Blood 2023, 142: 966. DOI: 10.1182/blood-2023-191109.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsMixed phenotype acute leukemiaRelapse-free survivalOverall survivalAcute lymphoblastic leukemiaComplete remissionPD-1Checkpoint inhibitorsExtramedullary diseaseAdverse eventsBM blastsGrade 3Positive B-cell acute lymphoblastic leukemiaResponse rateImmune-related adverse eventsB-cell acute lymphoblastic leukemiaMulti-center phase IPhase IDose-escalation schemaNon-hematologic toxicitiesMedian overall survivalDose-escalation studyPD-L1 expressionDuration of responseT cell subpopulationsPhase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trialA Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors
Garralda E, Schram A, Bedard P, Schwartz G, Yuen E, McNeely S, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. The Oncologist 2023, 29: e131-e140. PMID: 37531083, PMCID: PMC10769797, DOI: 10.1093/oncolo/oyad215.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsAdvanced solid tumorsCyclin-dependent kinase 7Adverse eventsSolid tumorsPhase I dose-escalation studyI dose-escalation studyLimited clinical activityGastrointestinal adverse eventsDose-escalation studyDose-limiting toxicityPhase I trialBest overall responsePeak-trough fluctuationKinase 7Common toxicitiesStable diseaseAbdominal painPrimary endpointSecondary endpointsAdult patientsPartial responseComplete responseI trialMedian timeNCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors
Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityHomologous recombination deficiencyPARP inhibitorsStable diseaseWeekly irinotecanObjective responseDay 1Day 3Solid tumorsPhase I dose-escalation studyTwice daily days 1I dose-escalation studyPhase I clinical trialDaily days 1Dose level 1Doses of veliparibGrade 3 neutropeniaMultiple-dose schedulesProgression-free survivalAdvanced solid tumorsDose-escalation studyEvaluable patientsNonoverlapping toxicitiesDose scheduleSystemic treatmentThe MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study
LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSolid tumorsDay 1Common treatment-related adverse eventsGrowth differentiation factor-15 levelsMDM2-p53 antagonistsManageable safety profileAdvanced solid tumorsDose-escalation studyDose-limiting toxicityMetastatic solid tumorsDose-dependent increaseIA/IBAdverse eventsSafety profilePreliminary efficacyDedifferentiated liposarcomaClinical investigationCommon gradePatientsRelated commentaryIssue featureTarget engagementAntitumor activityTumorsA phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1).
Winer I, Patnaik A, Barve M, Kummar S, Schenk E, LoRusso P, Yeku O, Fu S, Jahchan N, Myers M, Liang L, Deegan D, Jackson L, Li Y, Reyno L, Chamberlain M. A phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1). Journal Of Clinical Oncology 2023, 41: 2523-2523. DOI: 10.1200/jco.2023.41.16_suppl.2523.Peer-Reviewed Original ResearchSingle agentDose levelsNon-small cell lung cancerAdvanced refractory solid tumorsDose-escalation study designImmune-related adverse eventsTriple-negative breast cancerImmune checkpoint inhibitorsAcceptable safety profileDose-escalation studyRefractory solid tumorsCell lung cancerArchival tumor tissueEnrollment of subjectsImmune-related reactionsDose proportionalECOG PSRECIST 1.1Stable diseaseTREM1 expressionCheckpoint inhibitorsAdverse eventsPartial responseRadiographic responseGynecologic cancerFirst-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors.
Sommerhalder D, Hamilton E, Mukohara T, Yonemori K, Mita M, Yamashita T, Zheng J, Liu L, Maity A, Homji Mishra N, Bogg O, Li M, LoRusso P. First-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors. Journal Of Clinical Oncology 2023, 41: 1054-1054. DOI: 10.1200/jco.2023.41.16_suppl.1054.Peer-Reviewed Original ResearchWhite blood cellsEndocrine therapyPartial responsePart 1BPhase 1 dose-escalation studyHuman phase 1 studyPreclinical anti-tumor activityDurable partial responseTreatment-related AEsAdvanced solid tumorsDose-escalation studySystemic anticancer therapyPhase 1 studyAnti-tumor activityPart 1AEscalation studyMedian agePrior linesStandard therapyDose escalationCDK4/6 inhibitorsDisease progressionBreast cancerTumor biopsiesG1-2
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