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.
Part 1 \& 2: Approximately 51 subjects will be enrolled Part 3: Approximately 90 subjects will be enrolled
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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
Incidence of dose limiting toxicities at each dose levels (Part 1 only)
Time frame: 28 Days/End of Cycle 1
Incidence and severity of adverse events with each dose level
The intensity of adverse events will be graded as per CTCAE, Version 5.0 and categorized as serious adverse events or non-serious adverse events.
Time frame: upto 30 days of last dose
evaluation of Cmax (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations
Time frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)
evaluation of tmax (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations
Time frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)
evaluation of AUC (Part 1 and Part 2)
Pharmacokinetic analysis will be performed using non-compartmental analysis. The actual elapsed time from dose will be used in the final pharmacokinetic parameter calculations
Time frame: Through Cycle 1 and Cycle 2 (Each cycle of 28 Days)
tumour response
Time frame: Every 8 weeks, for 'Time point Response (Partial Response[PR], Stable Disease[SD], Disease progression [DP] or Complete Response [CR]), Through study completion, an average of 1 year.
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LMMF's Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Noble Hospital Pvt. Ltd.,
Pune, Maharashtra, India