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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02565758

Collaborator

(none)

Enrollment

Locations

Arms

42.2

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Sep 18, 2015

Actual Primary Completion Date :

Mar 25, 2019

Actual Study Completion Date :

Mar 25, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 [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. [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) [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) [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) [Up to 24 months]
DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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