Navid Hafez, MD, MPH
Assistant Professor AdjunctDownloadHi-Res Photo
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Assistant Professor (Medical Oncology)
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About
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Assistant Professor Adjunct
Assistant Professor (Medical Oncology)
Biography
Navid Hafez, MD, MPH completed his residency and fellowship at Yale and his received his medical degree from the University of Wisconsin School of Medicine and Public Health.
Appointments
Medical Oncology
Assistant Professor AdjunctPrimary
Other Departments & Organizations
- Developmental Therapeutics
- Internal Medicine
- Medical Oncology
- Subset Medical Oncology Faculty
- Yale Cancer Center
Education & Training
- MD
- University of Wisconsin Medical School (2010)
- MPH
- University of California at Berkeley (2004)
- BS
- University of Wisconsin (2001)
Research
Overview
Developmental therapeutics; immuno-oncology mechanisms of resistance and toxicity
Medical Research Interests
Clinical Trial; Clinical Trial, Phase I
ORCID
0000-0001-8115-9328
Research at a Glance
Yale Co-Authors
Frequent collaborators of Navid Hafez's published research.
Publications Timeline
A big-picture view of Navid Hafez's research output by year.
Patricia LoRusso, DO
Daniel P. Petrylak, MD
Michael Hurwitz, MD, PhD
Adebowale Adeniran, MD
David Rimm, MD, PhD
Kurt Schalper, MD, PhD
21Publications
178Citations
Publications
2024
669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors
Lorusso P, Meric-Bernstam F, Hafez N, Rivera I, Tripathy D, Wilks S, Pearson P, Needle M, Tolcher A. 669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors. Annals Of Oncology 2024, 35: s525. DOI: 10.1016/j.annonc.2024.08.735.Peer-Reviewed Original Research372 TABLET: food effect study of niraparib tablets in patients with advanced solid tumours
Richardson D, Falchook G, Donald Harvey R, Sharma M, Hafez N, Hamilton E, Patnaik A, Piha-Pau S, Barve M, Wise-Draper T, Patel M, Dowlati A, Pascuzzo J, Tang S, Faltermeier C, Malinowska I, Shtessel L, Striha A, Potocka E. 372 TABLET: food effect study of niraparib tablets in patients with advanced solid tumours. 2024, a257.1-a257. DOI: 10.1136/ijgc-2024-esgo.499.Peer-Reviewed Original ResearchEfficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.Peer-Reviewed Original ResearchCitationsAltmetricConceptsBiliary tract cancerAdvanced biliary tract cancerAdverse eventsDose reduction due to adverse eventsBiliary tract cancer casesChemotherapy plus immunotherapyPhase Ia/Ib trialPD-1 inhibitorsSecond-line optionAnti-tumor activityStable diseasePartial responsePD-1Treatment discontinuationCase seriesSafety profilePatientsImprove outcomesMolecular heterogeneityCancerMDM2-p53DiseaseImmunotherapyDoseEfficacyA Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors
Falchook G, Patnaik A, Richardson D, Harvey R, Sharma M, Hafez N, Hamilton E, Piha-Paul S, Barve M, Wise-Draper T, Patel M, Dowlati A, Pascuzzo J, Tang S, Faltermeier C, Malinowska I, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clinical Therapeutics 2024, 46: 228-238. PMID: 38423866, DOI: 10.1016/j.clinthera.2024.01.004.Peer-Reviewed Original ResearchCitationsConceptsHigh-fat mealFood effectPK parametersSolid tumorsGeometric least square meansAdvanced ovarian cancerAdvanced solid tumorsFood effect studyEstimate PK parametersSafety populationOpen-labelStandard therapyOvarian cancerPK variabilityFE stageMaintenance treatmentNiraparibDisease progressionSafety signalsTreatment periodInhibitor niraparibConcentration dataPatientsFasting stateCapsule formulationEfficacy 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 ResearchCitationsConceptsBiliary 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
2023
Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.Peer-Reviewed Original ResearchCitationsConceptsAdvanced biliary tract cancerBiliary tract cancerTreatment-related AEsMost common gradeMonotherapy trialsCombination trialsStable diseaseTract cancerExpansion trialGallbladder carcinomaCommon gradeAnti-PD-1 antibodyWhite blood cell countManageable safety profileAdvanced solid tumorsBiliary tract adenocarcinomaBlood cell countRange of malignanciesPreclinical antitumor activityNegative prognostic markerPotential antitumor strategyAmpullary adenocarcinomaIIb trialAmpullary carcinomaSafety profile
2022
Principles of Dose, Schedule, and Combination Therapy
Eder J, Hafez N. Principles of Dose, Schedule, and Combination Therapy. 2022, 1-13. DOI: 10.1002/9781119000822.hfcm055.pub3.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaCombination chemotherapyMonoclonal antibodiesChemotherapeutic agentsHigh single-agent activityContemporary cancer therapyContinuous oral administrationSingle-agent activityBone marrow transplantationClinical toxicity profileCytotoxic chemotherapeutic agentsDose-response effectTyrosine kinase inhibitorsOutcome of therapyRapid plasma clearanceClinical trial designCombination of agentsDeoxyribonucleic acid damaging agentsNormal tissue recoveryPolymerase inhibitor rucaparibRole of doseMost chemotherapeutic agentsPrecise pathologic diagnosisTumor cell sensitivityHematopoietic growth factorsDose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors.
Johnson M, Abdul-Karim R, Sommerhalder D, Hafez N, Wang S, Li C, Liu Y, Yang L, Collins S, Parot X, Strauss J. Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors. Journal Of Clinical Oncology 2022, 40: 2503-2503. DOI: 10.1200/jco.2022.40.16_suppl.2503.Peer-Reviewed Original ResearchAltmetricConceptsTreatment-related adverse eventsMetastatic solid tumorsAnti-drug antibodiesPhase 1b/2 studySolid tumorsDose escalationAttenuated cytokineGrade 4 thrombocytopeniaManageable safety profileMedian prior linesPhase 2 doseStrong clinical responseDose-escalation phaseInfusion-related reactionsDose-limiting toxicityProof of mechanismPreclinical mouse modelsImmune cell activationDose range 0.1IgG4 monoclonal antibodyQ3W dosingStable diseaseCheckpoint inhibitorsRefractory/Adverse eventsA phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.
Yamamoto N, Hafez N, Tolcher A, Teufel M, Geng J, Svensson L, Lahmar M, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3095-3095. DOI: 10.1200/jco.2022.40.16_suppl.3095.Peer-Reviewed Original ResearchCitationsAltmetricConceptsDose-limiting toxicityImmune checkpoint inhibitorsDoublet combinationsCheckpoint inhibitorsPrimary endpointPhase Ia/Ib studySolid tumorsManageable safety profileMDM2-p53 antagonistsProgression-free survivalAdvanced solid tumorsBiliary tract carcinomaMetastatic solid tumorsSoft tissue sarcomasAnti-tumor effectsWild-type cancersAnti-tumor activityLogistic regression modelsPhase IaMultiple tumor typesG3 anemiaG3 neutropeniaG4 thrombocytopeniaIA/IBMurine double minuteKRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation.
Bekaii-Saab T, Spira A, Yaeger R, Buchschacher G, McRee A, Sabari J, Johnson M, Barve M, Hafez N, Velastegui K, Christensen J, Kheoh T, Der-Torossian H, Rybkin I. KRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation. Journal Of Clinical Oncology 2022, 40: 519-519. DOI: 10.1200/jco.2022.40.4_suppl.519.Peer-Reviewed Original ResearchCitationsAltmetricConceptsDisease control rateKRAS G12C mutationProgression-free survivalPartial responseGI tumorsClinical activityG12C mutationPancreatic cancerSolid tumorsMedian progression-free survivalTreatment-related adverse eventsGrade 3/4 eventsGrade 5 eventsPhase 1/2 studyAdvanced solid tumorsMetastatic pancreatic cancerMetastatic solid tumorsEncouraging clinical activityPhase 2 cohortExtensive tissue distributionKRAS G12C inhibitorsFavorable pharmacokinetic propertiesEvaluable ptsKRASG12C mutationData cutoff
Academic Achievements & Community Involvement
activity National Comprehensive Cancer Network
Professional OrganizationsMemberDetailsMember06/01/2016 - Presentactivity American Society of Clinical Oncology
Professional OrganizationsMemberDetailsMember06/01/2013 - Present
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