2024
A first-in-human, phase 1/2 trial of FOG-001, a β-catenin:TCF antagonist, in patients with locally advanced or metastatic solid tumors.
Papadopoulos K, Rodon Ahnert J, Khushman M, Sharma S, Pelster M, Cecchini M, Kummar S, Choi M, Akella L, Garofalo A, Yu Z, Iyer V, Nguyen M, Orford K, Klempner S. A first-in-human, phase 1/2 trial of FOG-001, a β-catenin:TCF antagonist, in patients with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3175-tps3175. DOI: 10.1200/jco.2024.42.16_suppl.tps3175.Peer-Reviewed Original ResearchNon-small cell lung cancerMSS colorectal cancerMetastatic solid tumorsSolid tumorsColorectal cancerAdenomatous polyposis coliT cell factorB-cateninAntitumor activityWnt/b-cateninPhase 1/2 trialCell lung cancerFirst-in-humanTumor growth inhibitionActivate oncogenic pathwaysIntravenous (IVWnt pathwayPathway activating mutationsWnt/b-catenin pathwayWnt pathway genesCurative chemoradiationDose escalationDose expansionGastric/GEJ cancerEscalating dosesA phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation.
Heumann T, Stockton S, Cecchini M, Aljumaily R, Shyr C, Whisenant J, Starr J, Dayyani F, Baranda J, Trikalinos N, Ivy S, LoRusso P, Das S, Gore S, Beumer J, Berlin J. A phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation. Journal Of Clinical Oncology 2024, 42: 3077-3077. DOI: 10.1200/jco.2024.42.16_suppl.3077.Peer-Reviewed Original ResearchAdvanced solid tumorsMaximum tolerated doseDose escalationSolid tumorsPhase I study of irinotecanRecommended phase 2 doseRefractory advanced solid tumorsPhase 2 dosePhase I studyAnti-tumor activityBiweekly irinotecanInhibitor irinotecanIrinotecan exposureWeekly irinotecanTolerated doseDosing scheduleCancer xenograftsAdult patientsIrinotecanAssess safetyATR inhibitorsElimusertibSecondary objectivesDoseStandard careAbstract B026: Detection and characterization of DDR reversion alterations in baseline tissue and plasma samples from patients enrolled in the TRESR and ATTACC Phase I clinical trials
Silverman I, Schonhoft J, Jain E, Ulanet D, Yang J, Kim I, Fei K, Lagow E, Yablonovitch A, Cecchini M, Rosen E, Lee E, Lheureux S, Yap T, Fontana E, Koehler M, Rimkunas V. Abstract B026: Detection and characterization of DDR reversion alterations in baseline tissue and plasma samples from patients enrolled in the TRESR and ATTACC Phase I clinical trials. Cancer Research 2024, 84: b026-b026. DOI: 10.1158/1538-7445.dnarepair24-b026.Peer-Reviewed Original ResearchPoly(ADP-ribose) polymerase inhibitorsPhase I clinical trialDNA damage repairReversible alterationsECOG PS 0-1Baseline tissuePlatinum-based therapyPlasma samplesInterpretation of efficacy dataHRD-related genesDamage repairDDR alterationsTumor biopsiesOvarian cancerSingle nucleotide variantsWhole-genome sequencingDiagnostic challengeSolid tumorsClinical developmentEvaluate safetyEfficacy dataPolymerase inhibitorsTumorAtaxia telangiectasiaPatients
2023
NCI 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 treatment
2022
Impact of early detection on cancer curability: A modified Delphi panel study
Schwartzberg L, Broder M, Ailawadhi S, Beltran H, Blakely L, Budd G, Carr L, Cecchini M, Cobb P, Kansal A, Kim A, Monk B, Wong D, Campos C, Yermilov I. Impact of early detection on cancer curability: A modified Delphi panel study. PLOS ONE 2022, 17: e0279227. PMID: 36542647, PMCID: PMC9770338, DOI: 10.1371/journal.pone.0279227.Peer-Reviewed Original ResearchConceptsBlood testsLikelihood of benefitCancer typesEarly detectionEarly cancer detectionSolid tumorsTotal cancer incidenceAmerican Joint CommitteeLow cure rateRAND/UCLAPotential clinical benefitCancer detectionDelphi panel studyLong cancerClinical benefitCure ratePotential benefitsCancer curabilityMost cancer typesCancer incidenceHigh curabilityJoint CommitteeTreat cancersExpert consensusPanel consensus