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

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ClinicalTrials.gov Identifier: NCT02565758
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Undifferentiated Pleomorphic Sarcoma Squamous Cell Carcinoma of the Head and Neck Carcinoma of the Breast Drug: ABBV-085 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Actual Study Start Date : September 18, 2015
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 25, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A4 (ABBV-085)
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
 Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.
Experimental: Arm A3 (ABBV-085)
ABBV-085 will be administered at every cycle (28-day cycles).
 Drug: ABBV-085
Administered as an intravenous infusion in 28-day dosing cycles.


Outcome Measures
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Primary Outcome Measures :
  1. Terminal elimination half life of ABBV-085. [ Time Frame: UP to 24 months ]
  2. Maximum observed plasma concentration (Cmax) of ABBV-085. [ Time Frame: Up to 24 months ]
  3. Number of participants with Adverse Events [ Time Frame: Up to 24 months ]
    Collect all adverse events at each visit.

  4. Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 24 months ]
    ORR is defined as the proportion of the participants who achieve a complete response (CR) or partial response (PR).

  2. Progression free survival (PFS) [ Time Frame: 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.

  3. Duration of overall response (DOR) [ Time Frame: Up to 24 months ]
    DOR is defined as the time from the participant's initial CR or PR to the time of disease progression.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565758


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02565758    
Other Study ID Numbers: M15-394
2015-001645-84 ( EudraCT Number )
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Cancer
Advanced Solid Tumors
Neoplasm
Undifferentiated pleomorphic sarcoma
 squamous cell carcinoma of the head and neck
carcinoma of the breast
antibody drug conjugate
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Sarcoma
Squamous Cell Carcinoma of Head and Neck
Histiocytoma, Malignant Fibrous
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Head and Neck Neoplasms
Neoplasms by Site
Histiocytoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Breast Diseases
Skin Diseases