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

Primary Purpose

Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-085
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Arizona /ID# 148582
  • Scottsdale Healthcare /ID# 151349
  • University of California, Los Angeles /ID# 148586
  • Univ of Colorado Cancer Center /ID# 148581
  • University of Chicago /ID# 148579
  • Dana-Farber Cancer Institute /ID# 143782
  • Washington University-School of Medicine /ID# 151348
  • NYU Langone Medical Center /ID# 150786
  • Duke Univ Med Ctr /ID# 148200
  • Carolina BioOncology Institute /ID# 148583
  • University of Pennsylvania /ID# 148576
  • Greenville Hospital System /ID# 148652
  • Mary Crowley Cancer Research /ID# 148580
  • Univ TX, MD Anderson /ID# 147681
  • South Texas Accelerated Research Therapeutics /ID# 141715
  • Virginia Cancer Specialists /ID# 148584
  • Gustave Roussy /ID# 150300
  • Hospital Univ Ramon y Cajal /ID# 150799
  • Fundacion Jimenez Diaz /ID# 148564
  • Hosp Univ Madrid Sanchinarro /ID# 146039

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A4 (ABBV-085)

Arm A3 (ABBV-085)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Terminal elimination half life of ABBV-085.
Maximum observed plasma concentration (Cmax) of ABBV-085.
Number of participants with Adverse Events
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.
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)
ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).
Progression free survival (PFS)
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)
DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.

Full Information

First Posted
September 30, 2015
Last Updated
April 4, 2019
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02565758
Brief Title
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Official Title
A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Undifferentiated Pleomorphic Sarcoma, Squamous Cell Carcinoma of the Head and Neck, Carcinoma of the Breast
Keywords
Cancer, Advanced Solid Tumors, Neoplasm, Undifferentiated pleomorphic sarcoma, squamous cell carcinoma of the head and neck, carcinoma of the breast, antibody drug conjugate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A4 (ABBV-085)
Arm Type
Experimental
Arm Description
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Arm Title
Arm A3 (ABBV-085)
Arm Type
Experimental
Arm Description
ABBV-085 will be administered at every cycle (28-day cycles).
Intervention Type
Drug
Intervention Name(s)
ABBV-085
Intervention Description
Administered as an intravenous infusion in 28-day dosing cycles.
Primary Outcome Measure Information:
Title
Terminal elimination half life of ABBV-085.
Time Frame
UP to 24 months
Title
Maximum observed plasma concentration (Cmax) of ABBV-085.
Time Frame
Up to 24 months
Title
Number of participants with Adverse Events
Description
Collect all adverse events at each visit.
Time Frame
Up to 24 months
Title
Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
Description
AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.
Time Frame
Up 24 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).
Time Frame
Up to 24 months
Title
Progression free survival (PFS)
Description
PFS is defined as the time from the first dose date of ABBV-085 to either disease progression or death, whichever occurs first.
Time Frame
Up to 24 months
Title
Duration of overall response (DOR)
Description
DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona /ID# 148582
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Scottsdale Healthcare /ID# 151349
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258-4566
Country
United States
Facility Name
University of California, Los Angeles /ID# 148586
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 148581
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago /ID# 148579
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 143782
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University-School of Medicine /ID# 151348
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Medical Center /ID# 150786
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
Duke Univ Med Ctr /ID# 148200
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina BioOncology Institute /ID# 148583
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
University of Pennsylvania /ID# 148576
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Greenville Hospital System /ID# 148652
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Mary Crowley Cancer Research /ID# 148580
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Univ TX, MD Anderson /ID# 147681
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics /ID# 141715
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Cancer Specialists /ID# 148584
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Gustave Roussy /ID# 150300
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94805
Country
France
Facility Name
Hospital Univ Ramon y Cajal /ID# 150799
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz /ID# 148564
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp Univ Madrid Sanchinarro /ID# 146039
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35260879
Citation
Ray U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734.
Results Reference
derived

Learn more about this trial

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

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