2021
438 A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Chung C, Colevas A, Gibson M, Adkins D, Sukari A, Wirth L, Burtness B, Bauman J, Rodriguez C, Worden F, Saba N, Glisson B, Dunn L, Seiwert T, Agensky L, Levisetti M, Lynam R, Margossian S, Moniz R, Quayle S, Pienta K, Pai S. 438 A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. Journal For ImmunoTherapy Of Cancer 2021, 9: a468-a468. DOI: 10.1136/jitc-2021-sitc2021.438.Peer-Reviewed Original ResearchTreatment of HPV16Institutional review boardT cellsCombination cohortInterleukin-2HPV16 E7-specific CD8HPV16-specific T cellsPD-L1 tumor expressionRecurrent/metastatic headTumor-specific T cellsNeck squamous cell carcinomaAntigen-specific T cell activationSpecific T cell activationCTCAE grade 2Ongoing partial responsePhase 2 doseRECIST 1.1 criteriaAntitumor activityE7-specific CD8First-line treatmentAnti-tumor immunityPost-treatment biopsiesNatural killer cellsPhase 1 trialSquamous cell carcinomaPhase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies.
Muller C, Brown-Glaberman U, Chaney M, Garyantes T, LoRusso P, McQuade J, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Sato T, Yilmaz E, Rodon J. Phase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies. Journal Of Clinical Oncology 2021, 39: 3084-3084. DOI: 10.1200/jco.2021.39.15_suppl.3084.Peer-Reviewed Original ResearchG protein-coupled estrogen receptorC-Myc depletionStable diseaseDose levelsMetastatic solid tumor malignanciesAnti-PD-1 antibodyProtein-coupled estrogen receptorHr of dosingPhase 2 doseRECIST partial responseTreatment-related SAEsImmune checkpoint inhibitorsPhase 1 trialSolid tumor malignanciesPK/PD dataSelective small molecule agonistHigh unmet needDays of treatmentAnti-tumor activityEstrogen receptor agonistsSmall molecule agonistsTumor immune recognitionG protein-coupled receptorsAnti-cancer therapyCombination cohortTrial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Hong D, Strickler J, Fakih M, Falchook G, Li B, Durm G, Burns T, Ramalingam S, Goldberg S, Frank R, Marrone K, Shu C, Gandara D, Soman N, Henary H, Govindan R. Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101). Journal Of Clinical Oncology 2021, 39: tps2669-tps2669. DOI: 10.1200/jco.2021.39.15_suppl.tps2669.Peer-Reviewed Original ResearchNon-small cell lung cancerCombination regimensSolid tumorsG12C mutationKRAS p.Treatment-related adverse eventsAntitumor efficacyPhase 1b studyPrior systemic therapyOpen-label studyAdvanced solid tumorsDurable clinical benefitDose-limiting toxicityKey eligibility criteriaMetastatic solid tumorsAnticancer therapyCell lung cancerOncogenic driver mutationsCombination cohortManageable toxicityDose expansionPrimary endpointSecondary endpointsTolerability profileAdverse events
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
2018
Phase 1/1b dose escalation and expansion study of BEZ235, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumors including patients with advanced breast cancer
Rodon J, Pérez-Fidalgo A, Krop IE, Burris H, Guerrero-Zotano A, Britten CD, Becerra C, Schellens J, Richards DA, Schuler M, Abu-Khalaf M, Johnson FM, Ranson M, Edenfield J, Silva AP, Hackl W, Quadt C, Demanse D, Duval V, Baselga J. Phase 1/1b dose escalation and expansion study of BEZ235, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumors including patients with advanced breast cancer. Cancer Chemotherapy And Pharmacology 2018, 82: 285-298. PMID: 29882016, PMCID: PMC6286256, DOI: 10.1007/s00280-018-3610-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDose-Response Relationship, DrugDrug CompoundingFemaleHumansImidazolesMaleMiddle AgedNeoplasmsPhosphoinositide-3 Kinase InhibitorsQuinolinesTOR Serine-Threonine KinasesTrastuzumabConceptsAdvanced breast cancerSingle agentBreast cancerSolid tumorsHigh dosesPhase I/IbEnd pointDual PI3K/mTOR inhibitorContinuous daily scheduleDose-escalation partMost frequent AEsOpen-label studyPrimary end pointSecondary end pointsAdvanced solid tumorsPI3K/mTOR inhibitorCombination cohortConclusionsThe MTDGastrointestinal AEsPartial responseDose escalationFrequent AEsOral inhibitorResultsOne hundredLow dose
This site is protected by hCaptcha and its Privacy Policy and Terms of Service apply