2020
SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.
Beckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O'Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris III H. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Journal Of Clinical Oncology 2020, 38: tps1104-tps1104. DOI: 10.1200/jco.2020.38.15_suppl.tps1104.Peer-Reviewed Original ResearchMetastatic breast cancerMonomethyl auristatin EDose-expansion cohortsAntibody-drug conjugatesDose escalationBreast cancerRECIST v1.1Expansion cohortPrior linesCytotoxic chemotherapyMetastatic triple-negative breast cancerGrade 2 peripheral neuropathyInvestigational antibody-drug conjugateNegative metastatic breast cancerLIV-1Triple-negative breast cancerAdequate organ functionHumanized IgG1 monoclonal antibodyKey efficacy endpointsPrimary safety endpointProgression-free survivalDose-limiting toxicityDuration of responseOverall response rateMonths of completion
2017
Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial.
Spring L, Goel S, Juric D, Isakoff S, Haddad S, Habin K, Krop I, Moy B, Tolaney S, Bardia A. Trastuzumab emtansine (T-DM1) and ribociclib, an oral inhibitor of cyclin dependent kinase 4 and 6 (CDK 4/6), for patients with metastatic HER2-positive breast cancer: Phase 1b clinical trial. Journal Of Clinical Oncology 2017, 35: tps1106-tps1106. DOI: 10.1200/jco.2017.35.15_suppl.tps1106.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic HER2-positive breast cancerHER2-positive breast cancerObjective response rateProgression-free survivalMetastatic breast cancerT-DM1Breast cancerTrastuzumab emtansinePhase 1b clinical trialDose-expansion cohortsMTD/RP2DPhase 2 doseDose-escalation designPre-clinical modelsInhibition of CDK4/6Cyclin-dependent kinase 4Multiple effective therapiesHER receptor familyEligible patientsRECIST 1.1Most patientsPatient ageDependent kinase 4Escalation design