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

Phase 1TerminatedNCT03035279

AbbVie29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen: * History of inflammatory bowel disease * Active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism * History of primary immunodeficiency, allogenic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis * History of immune-mediated pneumonitis * Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment

Locations (9)

Highlands Oncology Group /ID# 201182

Fayetteville, Arkansas, United States

University of California, Los Angeles /ID# 160882

Los Angeles, California, United States

University of Michigan Hospitals /ID# 167101

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester /ID# 160884

Rochester, Minnesota, United States

Washington University-School of Medicine /ID# 160883

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center /ID# 160881

New York, New York, United States

Carolina BioOncology Institute /ID# 202712

Huntersville, North Carolina, United States

Oklahoma University /ID# 202713

Oklahoma City, Oklahoma, United States

Tennessee Oncology-Nashville Centennial /ID# 160880

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of participants with dose-limiting toxicities (DLT)

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 (21-day cycles)

Secondary Outcomes

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 2 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 2 years

Time to Cmax (Tmax) of SC-006

Time to Cmax of SC-006

Time frame: Approximately 1 year

Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006

Area under the plasma concentration-time curve within a dosing interval of SC-006

Time frame: Approximately 1 year

Duration of Clinical Benefit (DOCB)

DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.

Time frame: Approximately 2 years

Objective Response Rate (ORR)

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

Time frame: Approximately 2 years

Terminal half life (T1/2) of SC-006

Time frame: Approximately 1 year

Duration of response (DOR)

DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.

Time frame: Approximately 2 years

Observed plasma concentrations at trough (Ctrough) of SC-006

Observed plasma concentrations at trough of SC-006

Time frame: Approximately 1 year

Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)

CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).

Time frame: Approximately 2 years

Maximum observed serum concentration (Cmax) of SC-006

Maximum observed serum concentration of SC-006

Time frame: Approximately 1 year