NCT02565758

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
3 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

3.5 years

First QC Date

September 30, 2015

Last Update Submit

April 4, 2019

Conditions

Advanced Solid TumorsUndifferentiated Pleomorphic SarcomaSquamous Cell Carcinoma of the Head and NeckCarcinoma of the Breast

Keywords

CancerAdvanced Solid TumorsNeoplasmUndifferentiated pleomorphic sarcomasquamous cell carcinoma of the head and neckcarcinoma of the breastantibody drug conjugate

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Arm A4 (ABBV-085)

EXPERIMENTAL

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

Drug: ABBV-085

Arm A3 (ABBV-085)

EXPERIMENTAL

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

Drug: ABBV-085

Interventions

ABBV-085DRUG

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

Arm A3 (ABBV-085)Arm A4 (ABBV-085)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mayo Clinic Arizona /ID# 148582

Phoenix, Arizona, 85054, United States

Location

Scottsdale Healthcare /ID# 151349

Scottsdale, Arizona, 85258-4566, United States

Location

University of California, Los Angeles /ID# 148586

Los Angeles, California, 90095, United States

Location

Univ of Colorado Cancer Center /ID# 148581

Aurora, Colorado, 80045, United States

Location

University of Chicago /ID# 148579

Chicago, Illinois, 60637-1443, United States

Location

Dana-Farber Cancer Institute /ID# 143782

Boston, Massachusetts, 02215, United States

Location

Washington University-School of Medicine /ID# 151348

St Louis, Missouri, 63110, United States

Location

NYU Langone Medical Center /ID# 150786

New York, New York, 10016-6402, United States

Location

Duke Univ Med Ctr /ID# 148200

Durham, North Carolina, 27710, United States

Location

Carolina BioOncology Institute /ID# 148583

Huntersville, North Carolina, 28078, United States

Location

University of Pennsylvania /ID# 148576

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Greenville Hospital System /ID# 148652

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Cancer Research /ID# 148580

Dallas, Texas, 75230, United States

Location

Univ TX, MD Anderson /ID# 147681

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics /ID# 141715

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists /ID# 148584

Fairfax, Virginia, 22031, United States

Location

Gustave Roussy /ID# 150300

Villejuif, Île-de-France Region, 94805, France

Location

Hospital Univ Ramon y Cajal /ID# 150799

Madrid, 28034, Spain

Location

Fundacion Jimenez Diaz /ID# 148564

Madrid, 28040, Spain

Location

Hosp Univ Madrid Sanchinarro /ID# 146039

Madrid, 28050, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35260879DERIVED

MeSH Terms

Conditions

Histiocytoma, Malignant FibrousSquamous Cell Carcinoma of Head and NeckBreast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

HistiocytomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSarcomaCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialHead and Neck NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

September 18, 2015

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

April 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(16)ES(3)FR(1)