2021
498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01
Lee K, Chung H, Kim T, Lakhani N, Messersmith W, Santana-Davila R, Kim W, LoRusso P, Bang Y, Chow L, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 498 Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01. Journal For ImmunoTherapy Of Cancer 2021, 9: a530-a530. DOI: 10.1136/jitc-2021-sitc2021.498.Peer-Reviewed Original ResearchTreatment-related AEsGastroesophageal cancerCheckpoint inhibitorsAdvanced HNSCCEvaluable patientsHER2-positive gastroesophageal cancerNeck squamous cell carcinomaCytotoxic chemotherapy regimensLong-term PFSGastroesophageal junction cancerPhase 1 studyFavorable safety profileHER2-positive advanced gastricSquamous cell carcinomaAdaptive antitumor immunityWarrants further evaluationChemotherapy regimensPrimary endpointAdvanced gastricAdvanced malignanciesJunction cancerLine therapyMethods PatientsStandard chemotherapyAntitumor immunity
2020
A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy.
Chow L, Gainor J, Lakhani N, Lee K, Chung H, Lee J, LoRusso P, Bang Y, Hodi F, Santana-Davila R, Fanning P, Squifflet P, Jin F, Wan H, Kuo T, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy. Journal Of Clinical Oncology 2020, 38: 3056-3056. DOI: 10.1200/jco.2020.38.15_suppl.3056.Peer-Reviewed Original ResearchAdverse eventsCheckpoint inhibitorsData cutoffAdvanced malignanciesImmune responseNeck squamous cell cancerCommon being fatigueSquamous cell cancerStandard chemotherapy regimensAdaptive immune responsesHost immune responseAnti-cancer antibodiesCombination cohortAdvanced diseaseChemotherapy regimensGastroesophageal cancerStandard chemotherapyCell cancerPlatinum therapyExcellent tolerabilityHistoric controlsPharmacodynamic markersImmune cellsClinical activityTumor biopsies
2013
A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC).
Goncalves P, Kummar S, Siu L, Hansen A, Savvides P, Sukari A, Chao J, Heilbrun L, Pilat M, Smith D, Casetta L, Boerner S, LoRusso P. A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC). Journal Of Clinical Oncology 2013, 31: 6045-6045. DOI: 10.1200/jco.2013.31.15_suppl.6045.Peer-Reviewed Original ResearchProgression-free survivalAdenoid cystic carcinomaSuberoylanilide hydroxamic acidMetastatic adenoid cystic carcinomaOverall survivalAdverse eventsResponse durationResponse rateEvaluable patientsOnly grade 3 adverse eventGrade 3 adverse eventsMedian progression-free survivalTreatment of ACCAdequate organ functionMedian overall survivalPhase II studyPhase II trialHistone deacetylasesDrug combination studiesChemo-naïveChemotherapy regimensII trialOral painSecondary endpointsThromboembolic events
2012
Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens.
Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.Peer-Reviewed Original ResearchPaclitaxel/carboplatinMultiple chemotherapy regimensChemotherapy regimensWeekly dosingInterpatient variabilityLiposomal doxorubicinPK modelDose-proportional kineticsModerate interpatient variabilityPopulation PK modelPopulation PK modelingSMAC mimetic birinapantBlockade of apoptosisAdvanced malignanciesCombination regimensConcomitant administration
2006
Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors
Lorusso P, Heath E, Valdivieso M, Pilat M, Wozniak A, Gadgeel S, Shields A, Puchalski T, Ewesuedo R. Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 3034-3034. DOI: 10.1200/jco.2006.24.18_suppl.3034.Peer-Reviewed Original ResearchVascular endothelial growth factor receptorDose-limiting toxicityArm 1Chemotherapy regimensArm 2Arm 4Grade 3 hand-foot syndromeSolid tumorsGrade 4 neutropenic feverGrade 3 diarrheaGrade 3 fatigueGrade 3 hypertensionHand-foot syndromePhase I evaluationPre-treated patientsAdvanced solid tumorsPhase I trialEndothelial growth factor receptorSolid tumor patientsDuration of responseSelective inhibitorEfficacy/toxicityGrowth factor receptorIdentical chemotherapyNeutropenic fever
2001
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.Peer-Reviewed Original ResearchConceptsMetastatic breast carcinomaTreatment-related adverse eventsHand-foot syndromeBreast carcinomaAdverse eventsGrade 3 treatment-related adverse eventsCommon treatment-related adverse eventsResponse rateGrade 4 adverse eventsMetastatic breast carcinoma patientsPrevious chemotherapy regimensPrior anthracycline chemotherapyTreatment-related deathsPhase II studyPhase II trialBreast carcinoma patientsSubgroup of patientsOverall response rateCurrent multicenterFluoropyrimidine carbamateOral capecitabineAnthracycline chemotherapyChemotherapy regimensII trialTaxane therapy