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Brief Title: A Study in Patients With Advanced Breast Cancer
Official Title: A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients
Study ID: NCT04942054
Brief Summary: A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase Inhibitor/Fulvestrant/CDK4-6 inhibitors with or with out ESR1 mutation.
Detailed Description: Part 1 \& 2: Approximately 51 subjects will be enrolled Part 3: Approximately 90 subjects will be enrolled
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
The University of Chicago, Chicago, Illinois, United States
HealthCare Global Enterprises Ltd, Bangalore, Karnataka, India
HCG Manavata cancer Centre, Nashik, Maharashtra, India
LMMF's Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, India
Noble Hospital Pvt. Ltd.,, Pune, Maharashtra, India