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

Phase 1

Completed

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

• Registration Number: NCT02565758
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-18
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A4 (ABBV-085)	ABBV-085	ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Arm A3 (ABBV-085)	ABBV-085	ABBV-085 will be administered at every cycle (28-day cycles).

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of ABBV-085.	Up to 24 months
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.
Number of participants with Adverse Events	Up to 24 months	Collect all adverse events at each visit.
Terminal elimination half life of ABBV-085.	UP to 24 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (20)

Carolina BioOncology Institute /ID# 148583; 🇺🇸 Huntersville, North Carolina, United States

NYU Langone Medical Center /ID# 150786; 🇺🇸 New York, New York, United States

Greenville Hospital System /ID# 148652; 🇺🇸 Greenville, South Carolina, United States

Fundacion Jimenez Diaz /ID# 148564; 🇪🇸 Madrid, Spain

Washington University-School of Medicine /ID# 151348; 🇺🇸 Saint Louis, Missouri, United States

Hosp Univ Madrid Sanchinarro /ID# 146039; 🇪🇸 Madrid, Spain

Hospital Univ Ramon y Cajal /ID# 150799; 🇪🇸 Madrid, Spain

Scottsdale Healthcare /ID# 151349; 🇺🇸 Scottsdale, Arizona, United States

Gustave Roussy /ID# 150300; 🇫🇷 Villejuif, Ile-de-France, France

Mayo Clinic Arizona /ID# 148582; 🇺🇸 Phoenix, Arizona, United States

University of California, Los Angeles /ID# 148586; 🇺🇸 Los Angeles, California, United States

Univ of Colorado Cancer Center /ID# 148581; 🇺🇸 Aurora, Colorado, United States

University of Chicago /ID# 148579; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute /ID# 143782; 🇺🇸 Boston, Massachusetts, United States

Duke Univ Med Ctr /ID# 148200; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania /ID# 148576; 🇺🇸 Philadelphia, Pennsylvania, United States

Univ TX, MD Anderson /ID# 147681; 🇺🇸 Houston, Texas, United States

Mary Crowley Cancer Research /ID# 148580; 🇺🇸 Dallas, Texas, United States

Virginia Cancer Specialists /ID# 148584; 🇺🇸 Fairfax, Virginia, United States

South Texas Accelerated Research Therapeutics /ID# 141715; 🇺🇸 San Antonio, Texas, United States