Colorectal Cancer
Conditions
Keywords
Advanced colorectal cancer, Cancer, Metastatic colorectal cancer, Unresectable colorectal cancer, Maximum tolerated dose, Pharmacokinetics
Brief summary
This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.
Interventions
DRUGSC-006
Intravenous
DRUGABBV-181
Intravenous
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting. * Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 - 1. * Participants with adequate hematologic, hepatic, and renal function.
Exclusion criteria
* Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLT) | Minimum first cycle of dosing (21-day cycles) | 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 |
|---|---|---|
| Progression Free Survival (PFS) | Approximately 2 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. |
| Time to Cmax (Tmax) of SC-006 | Approximately 1 year | Time to Cmax of SC-006 |
| Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006 | Approximately 1 year | Area under the plasma concentration-time curve within a dosing interval of SC-006 |
| Duration of Clinical Benefit (DOCB) | Approximately 2 years | DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression. |
| Objective Response Rate (ORR) | Approximately 2 years | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Overall Survival (OS) | Approximately 2 years | OS is defined as the time from the participant's first dose date to death due to any cause. |
| Duration of response (DOR) | Approximately 2 years | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first. |
| Observed plasma concentrations at trough (Ctrough) of SC-006 | Approximately 1 year | Observed plasma concentrations at trough of SC-006 |
| Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD) | Approximately 2 years | CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD). |
| Maximum observed serum concentration (Cmax) of SC-006 | Approximately 1 year | Maximum observed serum concentration of SC-006 |
| Terminal half life (T1/2) of SC-006 | Approximately 1 year | Terminal half life (T1/2) of SC-006 |
Countries
United States
Outcome results
None listed