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Benefit/Risk Imbalance
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC-007 | Experimental | SC-007 intravenous (IV) (various doses and dose regimens) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC-007 | Drug | intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum first cycle of dosing (Up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) | CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Mayo Clinic |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Approximately 4 years |
| Observed plasma concentrations at trough (Ctrough) of SC-007 | Observed plasma concentrations at trough of SC-007 | Approximately 1 year |
| Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007 | Incidence of ATAs against SC-007 | 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. | Approximately 4 years |
| Terminal half life (T1/2) of SC-007 | Terminal half life of SC-007 | Approximately 1 year |
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants with complete response or partial response (CR+PR) | 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. | Approximately 4 years |
| Time to Cmax (Tmax) of SC-007 | Time to Cmax of SC-007 | 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 | Approximately 1 year |
| QTcF Change from Baseline | QT interval measurement corrected by Fridericia's formula (QTcF) | 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 | Approximately 1 year |
| Rochester |
| Minnesota |
| 55905-0001 |
| United States |
| Washington University-School of Medicine | St Louis | Missouri | 63110 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Tennessee Oncology-Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |