ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

Sponsors

Lead Sponsor: AbbVie

Source AbbVie
Brief Summary

This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

Overall Status Completed
Start Date 2015-09-18
Completion Date 2019-03-25
Primary Completion Date 2019-03-25
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Terminal elimination half life of ABBV-085. UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085. Up to 24 months
Number of participants with Adverse Events Up to 24 months
Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. Up 24 months
Secondary Outcome
Measure Time Frame
Objective response rate (ORR) Up to 24 months
Progression free survival (PFS) Up to 24 months
Duration of overall response (DOR) Up to 24 months
Enrollment 85
Condition
Intervention

Intervention Type: Drug

Intervention Name: ABBV-085

Description: Administered as an intravenous infusion in 28-day dosing cycles.

Eligibility

Criteria:

Inclusion Criteria: 1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens: - Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN). 4. All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies. 5. Participant has adequate bone marrow, renal, hepatic and cardiac function. 6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. Exclusion Criteria: 1. Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085. 2. Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-085. 3. Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia. 4. Participant has ongoing hemolysis. 5. Major surgery within <=28 days prior to the first dose of ABBV-085. 6. Clinically significant uncontrolled condition(s). 7. Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Location
Facility:
Mayo Clinic Arizona /ID# 148582 | Phoenix, Arizona, 85054, United States
Scottsdale Healthcare /ID# 151349 | Scottsdale, Arizona, 85258-4566, United States
University of California, Los Angeles /ID# 148586 | Los Angeles, California, 90095, United States
Univ of Colorado Cancer Center /ID# 148581 | Aurora, Colorado, 80045, United States
University of Chicago /ID# 148579 | Chicago, Illinois, 60637-1443, United States
Dana-Farber Cancer Institute /ID# 143782 | Boston, Massachusetts, 02215, United States
Washington University-School of Medicine /ID# 151348 | Saint Louis, Missouri, 63110, United States
NYU Langone Medical Center /ID# 150786 | New York, New York, 10016-6402, United States
Duke Univ Med Ctr /ID# 148200 | Durham, North Carolina, 27710, United States
Carolina BioOncology Institute /ID# 148583 | Huntersville, North Carolina, 28078, United States
University of Pennsylvania /ID# 148576 | Philadelphia, Pennsylvania, 19104-5502, United States
Greenville Hospital System /ID# 148652 | Greenville, South Carolina, 29605, United States
Mary Crowley Cancer Research /ID# 148580 | Dallas, Texas, 75230, United States
Univ TX, MD Anderson /ID# 147681 | Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics /ID# 141715 | San Antonio, Texas, 78229, United States
Virginia Cancer Specialists /ID# 148584 | Fairfax, Virginia, 22031, United States
Gustave Roussy /ID# 150300 | Villejuif, Ile-de-France, 94805, France
Hospital Univ Ramon y Cajal /ID# 150799 | Madrid, 28034, Spain
Fundacion Jimenez Diaz /ID# 148564 | Madrid, 28040, Spain
Hosp Univ Madrid Sanchinarro /ID# 146039 | Madrid, 28050, Spain
Location Countries

France

Spain

United States

Verification Date

2019-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm A4 (ABBV-085)

Type: Experimental

Description: ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson

Label: Arm A3 (ABBV-085)

Type: Experimental

Description: ABBV-085 will be administered at every cycle (28-day cycles).

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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