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

Brief Title

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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Terminal elimination half life of ABBV-085.

Secondary Outcome

 Objective response rate (ORR)

Condition

Advanced Solid Tumors

Intervention

ABBV-085

Study Arms / Comparison Groups

 Arm A4 (ABBV-085)
Description:  ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

85

Start Date

September 18, 2015

Completion Date

March 25, 2019

Primary Completion Date

March 25, 2019

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

AbbVie Inc., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02565758

Organization ID

M15-394

Secondary IDs

2015-001645-84

Responsible Party

Sponsor

Study Sponsor

AbbVie


Study Sponsor

AbbVie Inc., Study Director, AbbVie


Verification Date

April 2019