ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02565758 |
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Recruitment Status :
Completed
First Posted : October 1, 2015
Last Update Posted : April 5, 2019
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Solid Tumors Undifferentiated Pleomorphic Sarcoma Squamous Cell Carcinoma of the Head and Neck Carcinoma of the Breast | Drug: ABBV-085 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 85 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors |
| Actual Study Start Date : | September 18, 2015 |
| Actual Primary Completion Date : | March 25, 2019 |
| Actual Study Completion Date : | March 25, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A4 (ABBV-085)
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
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Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles. |
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Experimental: Arm A3 (ABBV-085)
ABBV-085 will be administered at every cycle (28-day cycles).
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Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles. |
Primary Outcome Measures :
- Terminal elimination half life of ABBV-085. [ Time Frame: UP to 24 months ]
- Maximum observed plasma concentration (Cmax) of ABBV-085. [ Time Frame: Up to 24 months ]
- Number of participants with Adverse Events [ Time Frame: Up to 24 months ]Collect all adverse events at each visit.
- Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. [ Time Frame: Up 24 months ]AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.
Secondary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: Up to 24 months ]ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).
- Progression free survival (PFS) [ Time Frame: Up to 24 months ]PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.
- Duration of overall response (DOR) [ Time Frame: Up to 24 months ]DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
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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).
- All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
- Participant has adequate bone marrow, renal, hepatic and cardiac function.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
Exclusion Criteria:
- Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
- 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.
- Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
- Participant has ongoing hemolysis.
- Major surgery within <=28 days prior to the first dose of ABBV-085.
- Clinically significant uncontrolled condition(s).
- Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565758
Locations
| United States, Arizona | |
| Mayo Clinic Arizona /ID# 148582 | |
| Phoenix, Arizona, United States, 85054 | |
| Scottsdale Healthcare /ID# 151349 | |
| Scottsdale, Arizona, United States, 85258-4566 | |
| United States, California | |
| University of California, Los Angeles /ID# 148586 | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Univ of Colorado Cancer Center /ID# 148581 | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| University of Chicago /ID# 148579 | |
| Chicago, Illinois, United States, 60637-1443 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute /ID# 143782 | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Washington University-School of Medicine /ID# 151348 | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| NYU Langone Medical Center /ID# 150786 | |
| New York, New York, United States, 10016-6402 | |
| United States, North Carolina | |
| Duke Univ Med Ctr /ID# 148200 | |
| Durham, North Carolina, United States, 27710 | |
| Carolina BioOncology Institute /ID# 148583 | |
| Huntersville, North Carolina, United States, 28078 | |
| United States, Pennsylvania | |
| University of Pennsylvania /ID# 148576 | |
| Philadelphia, Pennsylvania, United States, 19104-5502 | |
| United States, South Carolina | |
| Greenville Hospital System /ID# 148652 | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Mary Crowley Cancer Research /ID# 148580 | |
| Dallas, Texas, United States, 75230 | |
| Univ TX, MD Anderson /ID# 147681 | |
| Houston, Texas, United States, 77030 | |
| South Texas Accelerated Research Therapeutics /ID# 141715 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Virginia Cancer Specialists /ID# 148584 | |
| Fairfax, Virginia, United States, 22031 | |
| France | |
| Gustave Roussy /ID# 150300 | |
| Villejuif, Ile-de-France, France, 94805 | |
| Spain | |
| Hospital Univ Ramon y Cajal /ID# 150799 | |
| Madrid, Spain, 28034 | |
| Fundacion Jimenez Diaz /ID# 148564 | |
| Madrid, Spain, 28040 | |
| Hosp Univ Madrid Sanchinarro /ID# 146039 | |
| Madrid, Spain, 28050 | |
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02565758 History of Changes |
| Other Study ID Numbers: |
M15-394 2015-001645-84 ( EudraCT Number ) |
| First Posted: | October 1, 2015 Key Record Dates |
| Last Update Posted: | April 5, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by AbbVie:
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Cancer Advanced Solid Tumors Neoplasm Undifferentiated pleomorphic sarcoma |
squamous cell carcinoma of the head and neck carcinoma of the breast antibody drug conjugate |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Sarcoma Squamous Cell Carcinoma of Head and Neck Breast Neoplasms Histiocytoma, Malignant Fibrous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms, Connective and Soft Tissue Head and Neck Neoplasms |
Neoplasms by Site Breast Diseases Skin Diseases Histiocytoma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Antibodies Immunoglobulins Immunoconjugates Immunologic Factors Physiological Effects of Drugs |