drugset / Trial / NCT03035279

A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

NCT03035279

Phase 1 Terminated 29 enrolled AbbVie
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2017-03-08
Primary completion
2019-03-28
Completion
2019-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Budigalimab Monoclonal antibody Intravenous
Subject SC-006 Unknown Intravenous

Indications