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

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: Completed
• Conditions: Advanced Solid Tumors; Squamous Cell Carcinoma of the Head and Neck; Undifferentiated Pleomorphic Sarcoma; Carcinoma of the Breast
• Intervention / Treatment: Drug: ABBV-085

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	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	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.	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

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	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)	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)	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

• Sponsor: AbbVie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 25, 2019

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Advanced Solid Tumors; Neoplasm; squamous cell carcinoma of the head and neck; Undifferentiated pleomorphic sarcoma; antibody drug conjugate; carcinoma of the breast
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Head and Neck Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Squamous Cell; Neoplasms, Fibrous Tissue; Histiocytoma; Sarcoma; Breast Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Histiocytoma, Malignant Fibrous
• Other Study ID 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