Colorectal Cancer (CRC), Gastric Cancer
Conditions
Keywords
Cancer, Advanced cancer, Esophagogastric junction (EGJ) cancers, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics
Brief summary
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.
Interventions
DRUGSC-007
intravenous
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after: * CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well. * Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, hepatic, and renal function.
Exclusion criteria
* Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study. * Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult. * Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | Minimum first cycle of dosing (Up to 21 days) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cmax (Tmax) of SC-007 | Approximately 1 year | Time to Cmax of SC-007 |
| Clinical Benefit Rate (CBR) | Approximately 4 years | CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD). |
| Progression Free Survival (PFS) | Approximately 4 years | 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. |
| Observed plasma concentrations at trough (Ctrough) of SC-007 | Approximately 1 year | Observed plasma concentrations at trough of SC-007 |
| Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007 | Approximately 4 years | Incidence of ATAs against SC-007 |
| Duration of Response (DOR) | Approximately 4 years | 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. |
| Terminal half life (T1/2) of SC-007 | Approximately 1 year | Terminal half life of SC-007 |
| Objective Response Rate (ORR) | Approximately 4 years | ORR is defined as the proportion of participants with complete response or partial response (CR+PR) |
| Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007 | Approximately 1 year | Area under the plasma concentration-time curve within a dosing interval of SC-007 |
| QTcF Change from Baseline | Up to 9 weeks based on 3 cycles of dosing (21-day cycles) | QT interval measurement corrected by Fridericia's formula (QTcF) |
| Maximum observed serum concentration (Cmax) of SC-007 | Approximately 1 year | Maximum observed serum concentration of SC-007 |
| Overall Survival (OS) | Approximately 4 years | OS is defined as the time from the participant's first dose date to death due to any cause. |
Countries
United States
Outcome results
None listed