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

NCT03035279 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: M16-312
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

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.

Conditions

Colorectal Cancer

Keywords

Advanced colorectal cancer; Cancer; Metastatic colorectal cancer; Unresectable colorectal cancer; Maximum tolerated dose; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  Minimum first cycle of dosing (21-day cycles)

Secondary Outcomes (11)

• Overall Survival (OS)

  Approximately 2 years

• Progression Free Survival (PFS)

  Approximately 2 years

• Time to Cmax (Tmax) of SC-006

  Approximately 1 year

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

  Approximately 1 year

• Duration of Clinical Benefit (DOCB)

  Approximately 2 years

Study Arms (3)

Arm A

EXPERIMENTAL

SC-006 Dose regimen finding

Drug: SC-006

Arm B

EXPERIMENTAL

SC-006 Dose expansion

Drug: SC-006

Arm C

EXPERIMENTAL

SC-006 and ABBV-181 Combination escalation and expansion

Drug: SC-006; Drug: ABBV-181

Interventions

SC-006 DRUG

Intravenous

Arm A; Arm B; Arm C

ABBV-181 DRUG

Intravenous

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

Highlands Oncology Group /ID# 201182

Fayetteville, Arkansas, 72703-4005, United States

Location

University of California, Los Angeles /ID# 160882

Los Angeles, California, 90095, United States

Location

University of Michigan Hospitals /ID# 167101

Ann Arbor, Michigan, 48109-5008, United States

Location

Mayo Clinic - Rochester /ID# 160884

Rochester, Minnesota, 55905-0001, United States

Location

Washington University-School of Medicine /ID# 160883

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center /ID# 160881

New York, New York, 10065-6007, United States

Location

Carolina BioOncology Institute /ID# 202712

Huntersville, North Carolina, 28078, United States

Location

Oklahoma University /ID# 202713

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 160880

Nashville, Tennessee, 37203-1632, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 30, 2017
• Study Start: March 8, 2017
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)