2024
First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors.
Chandana S, Choudhury N, Dowlati A, Chiang A, Garmezy B, Kim J, Byers L, Ahn M, Kim T, Kim Y, Han J, Bar J, Zha J, Henner W, Robinson R, KOHLHAPP F, Hingorani P, Papadopoulos K. First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2024, 42: 3001-3001. DOI: 10.1200/jco.2024.42.16_suppl.3001.Peer-Reviewed Original ResearchSmall cell lung cancerAntibody-drug conjugatesDose escalationNeuroendocrine neoplasmsCentral nervous systemRelapsed/refractory small cell lung cancerApproximate dose-proportional increasesHigh-grade CNS tumorsRecommended phase 2 doseModels of small cell lung cancerHigh-grade neuroendocrine neoplasmsFirst-in-human studyCentral nervous system tumorsClinical benefit rateDose-expansion studyMedian prior linesPhase 2 doseDose-limiting toxicityMaximum tolerated doseDose-proportional increaseCell lung cancerHigh-grade gliomasElimination half-lifeBayesian optimal interval designData cutoff
2023
First-in-human study of ABBV-011, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in patients with small cell lung cancer.
Morgensztern D, Ready N, Johnson M, Dowlati A, Choudhury N, Carbone D, Schaefer E, Arnold S, Puri S, Piotrowska Z, Hegde A, Chiang A, Iams W, Tolcher A, Nosaki K, Zha J, Li R, Hingorani P, Jeng E, Furqan M. First-in-human study of ABBV-011, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in patients with small cell lung cancer. Journal Of Clinical Oncology 2023, 41: 3002-3002. DOI: 10.1200/jco.2023.41.16_suppl.3002.Peer-Reviewed Original ResearchSmall cell lung cancerTreatment-emergent adverse eventsClinical benefit rateMaximum tolerated doseAntibody-drug conjugatesCell lung cancerDose escalationMedian durationLung cancerProgrammed cell death-1 inhibitorRelapsed/refractory small cell lung cancerSmall cell lung cancer tumorsConfirmed objective response rateMedian duration of responseRecommended phase 2 doseModels of small cell lung cancerMedian duration of treatmentVeno-occlusive liver diseaseFirst-in-human studyAntitumor activityObjective response rateDose-limiting toxicityProgression-free survivalDuration of responseDuration of treatment
2014
1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study
Pietanza M, Spira A, Jotte R, Gadgeel S, Mita A, Liu S, Gluck W, Kalemkerian G, Chiang A, Hart L, Kapoun A, Xu L, Hill D, Zhou L, Dupont J, Spigel D. 1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study. Annals Of Oncology 2014, 25: iv514. DOI: 10.1093/annonc/mdu355.11.Peer-Reviewed Original ResearchDose-limiting toxicityAnti-tumor activityDay 1Untreated extensive stage small cell lung cancerExtensive-stage small-cell lung cancerMain dose-limiting toxicitySmall cell lung cancerGrade 3 diarrheaGrade 3 nauseaPhase 2 partPhase 1b trialPK/pharmacodynamicsED-SCLCSCLC xenograftsDose cohortsRECIST 1.1Peripheral edemaUnacceptable toxicityAdverse eventsSupportive carePreliminary efficacyLung cancerDisease progressionEfficacy dataIgG2 antibodies