A Phase 1 interventional study of SC-007 in Colorectal Cancer (CRC) and Gastric Cancer, sponsored by AbbVie. Terminated at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-27.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
Exclusion Criteria:
SC-007 intravenous (IV) (various doses and dose regimens)
Drug: SC-007
intravenous
Number of participants with dose-limiting toxicities (DLTs)
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 (Up to 21 days)
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).
Time frame: Approximately 4 years
Progression Free Survival (PFS)
PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.
Time frame: Approximately 4 years
Observed plasma concentrations at trough (Ctrough) of SC-007
Observed plasma concentrations at trough of SC-007
Time frame: Approximately 1 year
Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
Incidence of ATAs against SC-007
Time frame: Approximately 4 years
Overall Survival (OS)
OS is defined as the time from the participant's first dose date to death due to any cause.
Time frame: Approximately 4 years
Terminal half life (T1/2) of SC-007
Terminal half life of SC-007
Time frame: Approximately 1 year
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time frame: Approximately 4 years
Duration of Response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Time frame: Approximately 4 years
Time to Cmax (Tmax) of SC-007
Time to Cmax of SC-007
Time frame: Approximately 1 year
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
Area under the plasma concentration-time curve within a dosing interval of SC-007
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)
Maximum observed serum concentration (Cmax) of SC-007
Maximum observed serum concentration of SC-007
Time frame: Approximately 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie