This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
University of Alabama /ID# 202249
Birmingham, Alabama, United States
Highlands Oncology Group /ID# 209165
Fayetteville, Arkansas, United States
City of Hope /ID# 202493
Duarte, California, United States
Number of participants with dose-limiting toxicities (DLT)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time frame: Minimum first cycle of dosing (21-day cycles)
Observed plasma concentrations at trough (Ctrough)
Observed plasma concentrations at trough.
Time frame: Approximately 1 year
Overall Survival (OS)
OS is defined as the time from the subject's first dose date to death due to any cause.
Time frame: Approximately 2 years
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).
Time frame: Approximately 2 years
Terminal half life (T1/2)
Terminal half life (T1/2).
Time frame: Approximately 1 year
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration.
Time frame: Approximately 1 year
Time to Cmax (Tmax)
Time to Cmax.
Time frame: Approximately 1 year
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).
Time frame: Approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Chicago /ID# 200735
Chicago, Illinois, United States
Henry Ford Health System /ID# 202480
Detroit, Michigan, United States
Mayo Clinic - Rochester /ID# 200732
Rochester, Minnesota, United States
Washington University School /ID# 164091
St Louis, Missouri, United States
The Ohio State University - Columbus /ID# 164089
Columbus, Ohio, United States
Univ Oklahoma HSC /ID# 164090
Oklahoma City, Oklahoma, United States
Tennessee Oncology-Nashville Centennial /ID# 164088
Nashville, Tennessee, United States
...and 2 more locations
Progression Free Survival (PFS)
PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1.
Time frame: Approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment.
Time frame: Approximately 2 years
Area under the plasma concentration-time curve within a dosing interval (AUC)
Area under the plasma concentration-time curve within a dosing interval.
Time frame: Approximately 1 year
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF).
Time frame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Duration of Clinical Benefit (DOCB)
DOCB is defined as the time from a subject's objective response (CR or PR) or stable disease (SD) to study drug therapy to disease progression or death due to any cause whichever occurs first.
Time frame: Approximately 2 years