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

AbbVie20 sites in 3 countries85 target enrollmentSeptember 18, 2015

ConditionsAdvanced Solid Tumors Undifferentiated Pleomorphic Sarcoma Squamous Cell Carcinoma of the Head and Neck Carcinoma of the Breast

InterventionsABBV-085

DrugsABBV-085

Overview

Phase: Phase 1
Intervention: ABBV-085
Conditions: Advanced Solid Tumors
Sponsor: AbbVie
Enrollment: 85
Locations: 20
Primary Endpoint: Maximum observed plasma concentration (Cmax) of ABBV-085.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 18, 2015

End Date

March 25, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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
•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-
•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-
•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-
•Clinically significant uncontrolled condition(s).
•Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.