Clinical trial NCT02565758: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Terminal elimination half life of ABBV-085.
timeFrame: UP to 24 months
measure: Maximum observed plasma concentration (Cmax) of ABBV-085.
timeFrame: Up to 24 months
measure: Number of participants with Adverse Events
timeFrame: Up to 24 months
measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
timeFrame: Up 24 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 months
measure: Progression free survival (PFS)
timeFrame: Up to 24 months
measure: Duration of overall response (DOR)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 148582
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare /ID# 151349
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 148586
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 148581
state: Colorado
city: Chicago
country: United States
facility: University of Chicago /ID# 148579
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 143782
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 151348
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center /ID# 150786
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr /ID# 148200
state: North Carolina
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 148583
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 148576
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System /ID# 148652
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Cancer Research /ID# 148580
state: Texas
city: Houston
country: United States
facility: Univ TX, MD Anderson /ID# 147681
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics /ID# 141715
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists /ID# 148584
state: Virginia
city: Villejuif
country: France
facility: Gustave Roussy /ID# 150300
state: Ile-de-France
city: Madrid
country: Spain
facility: Hospital Univ Ramon y Cajal /ID# 150799
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz /ID# 148564
city: Madrid
country: Spain
facility: Hosp Univ Madrid Sanchinarro /ID# 146039
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.