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Completed

NCT Number: NCT02565758

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

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.

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Key information

Conditions

Advanced Solid Tumors Breast Diseases Breast Neoplasms Carcinoma Carcinoma of the Breast Carcinoma, Squamous Cell Head and Neck Neoplasms Histiocytoma Histiocytoma, Malignant Fibrous Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Glandular and Epithelial Sarcoma Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Head and Neck Undifferentiated Pleomorphic Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gustave Roussy /ID# 150300, Villejuif, Île-de-France Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 2.
  • 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-085.
  • 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.
  • 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-085.
  • Clinically significant uncontrolled condition(s).
  • Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.

Treatment and study plan

ABBV-085

Drug

Administered as an intravenous infusion in 28-day dosing cycles.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2015
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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