A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

November 28, 2018 updated by: AbbVie

A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose Escalation and Expanded Recommended Phase 2 Dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Sydney Children's Hospital /ID# 162917
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae /ID# 162918
  • Denmark
    • Hovedstaden
      • Copenhagen Ø, Hovedstaden, Denmark, 2100
        • Rigshospitalet /ID# 159707
  • Spain
      • Madrid, Spain, 28050
        • Hosp Univ Madrid Sanchinarro /ID# 161644
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258-2345
        • HonorHealth Research Institute - Pima /ID# 161078
    • California
      • Duarte, California, United States, 91010
        • City of Hope /ID# 161079
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University /ID# 201357
    • Missouri
      • Kansas City, Missouri, United States, 64111-5905
        • St. Lukes Cancer Institute /ID# 201353
      • Saint Louis, Missouri, United States, 63110
        • Washington University-School of Medicine /ID# 162745
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of NJ /ID# 161080
    • Utah
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 161606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant has histological confirmation of a locally advanced or metastatic solid tumor of a type associated with Prolactin Receptor (PRLR) expression that has progressed on prior treatment, is not amenable to treatment with curative intent, and has no other therapy options known to provide clinical benefit or the subject is ineligible for such therapies.
  • Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma.
  • Expanded Cohort: must have breast cancer.
  • Participant must consent to provide the following for biomarker analyses:
  • Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
  • Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
  • Participant has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Participant has adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

  • Participant received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic, or any investigational therapy within 21 days before Study Day 1; participant received palliative radiotherapy or small molecule targeted anti-cancer agents within 14 days of Study Day 1.
  • Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
  • Participant has unresolved, clinically significant toxicities from prior anticancer therapy, defined as greater than Grade 1 on Common Terminology for adverse events.
  • Participant has clinically significant uncontrolled conditions.
  • Participant has a history of major immunologic reaction to any Immunoglobulin G (IgG).

  • Participant has received more than 4 prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy).

    • For prior cytotoxic therapy, treatment for 1 full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy.
  • Participant has a history of >= grade 3 AST, ALT, or bilirubin increase or has extensive liver resection (i.e., left lobe resection).
  • Participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation Cohort
ABBV-176 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached.
Drug: ABBV-176
Intravenous infusion
Experimental: Expanded RPTD Cohort
ABBV-176 via intravenous administration in participants with breast cancer at the Recommended Phase Two Dose (RPTD) determined during the Dose Escalation Cohort
Drug: ABBV-176
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Escalation Cohort: Tmax of ABBV-176
Time Frame: Up to approximately 57 days
Time to Cmax (Tmax) of ABBV-176
Up to approximately 57 days
Dose Escalation Cohort: AUC∞ for ABBV-176
Time Frame: Up to approximately 57 days
AUC∞ is the area under the plasma concentration-time curve from Time 0 to infinite time.
Up to approximately 57 days
Dose Escalation Cohort: Terminal phase elimination rate constant (β) for ABBV-176
Time Frame: Up to approximately 57 days
Terminal phase elimination rate constant (β)
Up to approximately 57 days
Dose Escalation Cohort: Recommended Phase 2 dose (RPTD) for ABBV-176
Time Frame: Minimum first cycle of dosing (up to 21 days)
The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Cohort.
Minimum first cycle of dosing (up to 21 days)
Dose Escalation Cohort: Cmax of ABBV-176
Time Frame: Up to approximately 57 days
Maximum observed plasma concentration (Cmax) of ABBV-176.
Up to approximately 57 days
Dose Escalation Cohort: Maximum tolerated dose (MTD) of ABBV-176
Time Frame: Minimum first cycle of dosing (up to 21 days)
MTD will be defined as the highest dose level at which less than or equal to 33% of participants experience a dose limiting toxicity.
Minimum first cycle of dosing (up to 21 days)
Expanded Recommended Phase Two Dose (RPTD) Cohort: Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
ORR is defined as the proportion of participants with a response of partial response (PR) or better per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Up to approximately 2 years
Dose Escalation Cohort: AUCt for ABBV-176
Time Frame: Up to approximately 57 days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-176.
Up to approximately 57 days
Dose Escalation Cohort: t1/2 for ABBV-176
Time Frame: Up to approximately 57 days
Terminal elimination half-life (t1/2)
Up to approximately 57 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expanded RPTD Cohort: AUCt for ABBV-176
Time Frame: Up to approximately 15 days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
Up to approximately 15 days
Expanded RPTD Cohort: Tmax of ABBV-176
Time Frame: Up to approximately 15 days
Time to Cmax (Tmax) of ABBV-176
Up to approximately 15 days
Expanded RPTD Cohort: Overall Survival (OS)
Time Frame: Up to 2 years after the last dose of study drug
OS is defined as number of days from the date of the first dose to the date of death for all dosed subjects. For subjects who are not deceased, the data will be censored at the date of the last study visit, or the last know date to be alive, whichever is later.
Up to 2 years after the last dose of study drug
Expanded RPTD Cohort: Cmax of ABBV-176
Time Frame: Up to approximately 15 days
Maximum observed plasma concentration (Cmax) of ABBV-176.
Up to approximately 15 days
Expanded RPTD Cohort: Duration of Response (DOR)
Time Frame: Up to approximately 2 years
DOR is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
Up to approximately 2 years
Expanded RPTD Cohort: Terminal phase elimination rate constant (β) for ABBV-176
Time Frame: Up to approximately 15 days
Terminal phase elimination rate constant (β) for ABBV-176
Up to approximately 15 days
Expanded Recommended Phase Two Dose (RPTD) Cohort: Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
PFS is defined as the time from the participant's first dose of study drug (Day 1) to the date of documented disease progression (per RECIST 1.1), or death due to any cause, whichever occurs first.
Up to approximately 2 years
Expanded RPTD Cohort: Change in ECOG Performance Status
Time Frame: Up to approximately 2 years
Change from baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Up to approximately 2 years
Expanded RPTD Cohort: AUC∞ for ABBV-176
Time Frame: Up to approximately 15 days
Area Under the Plasma Concentration-time Curve from Time 0 to infinite time (AUC∞)
Up to approximately 15 days
Expanded RPTD Cohort: t1/2 for ABBV-176
Time Frame: Up to approximately 15 days
Terminal elimination half-life (t1/2) for ABBV-176
Up to approximately 15 days
Dose Escalation Cohort: Change from Baseline in QTcF
Time Frame: Up to approximately 47 days
QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline
Up to approximately 47 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M15-916
  • 2016-004597-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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