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

Advanced Solid Tumors Clinical Trial

Official title:

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565758
• Other study ID #: M15-394
• Secondary ID: 2015-001645-84
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2015
• Est. completion date: March 25, 2019

Study information

• Verified date: April 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Breast Neoplasms
• Carcinoma
• Carcinoma of the Breast
• Carcinoma, Squamous Cell
• Histiocytoma, Malignant Fibrous
• Sarcoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck
• Undifferentiated Pleomorphic Sarcoma

Intervention

Drug:
• ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.

Locations

Country	Name	City	State
France	Gustave Roussy /ID# 150300	Villejuif	Ile-de-France
Spain	Fundacion Jimenez Diaz /ID# 148564	Madrid
Spain	Hosp Univ Madrid Sanchinarro /ID# 146039	Madrid
Spain	Hospital Univ Ramon y Cajal /ID# 150799	Madrid
United States	Univ of Colorado Cancer Center /ID# 148581	Aurora	Colorado
United States	Dana-Farber Cancer Institute /ID# 143782	Boston	Massachusetts
United States	University of Chicago /ID# 148579	Chicago	Illinois
United States	Mary Crowley Cancer Research /ID# 148580	Dallas	Texas
United States	Duke Univ Med Ctr /ID# 148200	Durham	North Carolina
United States	Virginia Cancer Specialists /ID# 148584	Fairfax	Virginia
United States	Greenville Hospital System /ID# 148652	Greenville	South Carolina
United States	Univ TX, MD Anderson /ID# 147681	Houston	Texas
United States	Carolina BioOncology Institute /ID# 148583	Huntersville	North Carolina
United States	University of California, Los Angeles /ID# 148586	Los Angeles	California
United States	NYU Langone Medical Center /ID# 150786	New York	New York
United States	University of Pennsylvania /ID# 148576	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona /ID# 148582	Phoenix	Arizona
United States	Washington University-School of Medicine /ID# 151348	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics /ID# 141715	San Antonio	Texas
United States	Scottsdale Healthcare /ID# 151349	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Terminal elimination half life of ABBV-085.		UP to 24 months
Primary	Maximum observed plasma concentration (Cmax) of ABBV-085.		Up to 24 months
Primary	Number of participants with Adverse Events	Collect all adverse events at each visit.	Up to 24 months
Primary	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	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
Secondary	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
Secondary	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