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

April 4, 2019 updated by: AbbVie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A4 (ABBV-085)
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Experimental: Arm A3 (ABBV-085)
ABBV-085 will be administered at every cycle (28-day cycles).
Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Terminal elimination half life of ABBV-085.
Time Frame: UP to 24 months
UP to 24 months
Maximum observed plasma concentration (Cmax) of ABBV-085.
Time Frame: Up to 24 months
Up to 24 months
Number of participants with Adverse Events
Time Frame: Up to 24 months
Collect all adverse events at each visit.
Up to 24 months
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.
Up 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M15-394
  • 2015-001645-84 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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