2024
Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma.
Ulahannan S, Marron T, Park H, Kaczmar J, Stephenson R, Lakhani N, Durm G, Grewal J, El-Khoueiry A, Luke J, Beers C, Murugappan S, LoRusso P, Adkins D, Hecht J. Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma. Journal Of Clinical Oncology 2024, 42: 2524-2524. DOI: 10.1200/jco.2024.42.16_suppl.2524.Peer-Reviewed Original ResearchHead and neck squamous cell carcinomaMetastatic colorectal cancerNeck squamous cell carcinomaSquamous cell carcinomaPreliminary efficacy dataCell carcinomaColorectal cancerEfficacy dataSolid tumor cohortTreatment-related AEsImmune cell changesAnti-tumor activityStandard of careRandomized controlled studyDose escalationEscalating dosesHLA-G.Peripheral bloodTumor cohortsSolid tumorsDecreased appetiteAST increaseBlood samplesCell changesQ3W
2019
Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors.
Sachdev J, Bauer T, Chawla S, Pant S, Patnaik A, Wainberg Z, Inamdar S, Marina N, Sun S, Schmidt M, Xiang H, LoRusso P. Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. Journal Of Clinical Oncology 2019, 37: 2529-2529. DOI: 10.1200/jco.2019.37.15_suppl.2529.Peer-Reviewed Original ResearchTreatment-related AEsAdvanced solid tumorsB7-H4Solid tumorsExploration cohortEndometrial cancerDose escalationTreatment-related serious adverse eventsAntibody-dependent cell-mediated cytotoxicityB7-H4 antibodyDose-proportional exposureSerious adverse eventsT cell activityCell-mediated cytotoxicityFavorable safety profileT cell functionAnti-tumor activityPreliminary biomarkerPrior therapyTreatment biopsiesAdverse eventsMost patientsSafety profileB7 familyEfficacy data
2012
A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors.
Han H, Tan A, Weiss G, Sullivan D, Strosberg J, Collins S, Moss R, Wu J, Ewesuedo R, LoRusso P. A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2534-2534. DOI: 10.1200/jco.2012.30.15_suppl.2534.Peer-Reviewed Original ResearchTopoisomerase I inhibitorDay scheduleCell lungTreatment-emergent adverse eventsNon-small cell lungEmergent adverse eventsPhase I safetyAdvanced solid tumorsAccelerated titration designPK-PD relationshipSmall cell lungDistinct clinical profileDose-exposure relationshipPharmacokinetic-pharmacodynamic modelI inhibitorNon-camptothecin topoisomerase I inhibitorsStable diseaseI safetyAdverse eventsPhase I developmentWeekly dosesClinical profileEfficacy dataTitration designSafety data
2008
355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449
Rudin C, Von Hoff D, LoRusso P, Vernillet L, Yauch R, Darbonne W, Mackey H, de Sauvage F, Low J, Reddy J. 355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449. European Journal Of Cancer Supplements 2008, 6: 112-113. DOI: 10.1016/s1359-6349(08)72289-4.Peer-Reviewed Original Research
2007
AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study
Shields A, Heath E, DeLuca P, Pilat M, Wozniak A, Gadgeel S, Puchalski T, Xu J, Liu Q, LoRusso P. AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study. Journal Of Clinical Oncology 2007, 25: 3544-3544. DOI: 10.1200/jco.2007.25.18_suppl.3544.Peer-Reviewed Original ResearchAnticancer regimensApparent PK interactionsCommon adverse eventsObjective tumor responseAdvanced solid tumorsPotential pharmacokinetic interactionsCell lung cancerMulti-cohort studyNovel study designPK parameter valuesStable diseaseAdverse eventsPartial responsePharmacokinetic interactionsTreatment armsClinical benefitSafety profileLung cancerPK interactionsTumor responseRecent trialsEfficacy dataAZD2171Unexpected toxicitiesCombination treatment