A Study in Adult Subjects With Select Advanced Solid Tumors

January 7, 2019 updated by: MedImmune LLC

A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors

To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

Study Overview

Status

Status

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

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.

Detailed Description

This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

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.
40

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • Los Angeles, California, United States, 90025
        • Research Site
    • Florida
      • Tampa, Florida, United States, 33612
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Houston, Texas, United States, 77521
        • Research Site

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:

  • All subjects must consent to provide archived tumor specimen
  • Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
  • At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
  • Willingness to provide pretreatment and on-treatment biopsies.
  • Adequate organ function
  • Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception

Exclusion Criteria:

  • Known allergic reaction to any component of MEDI1873
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
  • Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
  • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
  • Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
  • Unresolved toxicities from prior anticancer therapy
  • Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Monotherapy arm
MEDI1873
Biological: MEDI1873
Subjects will receive MEDI1873 by intravenous administration

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
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time Frame: From time of informed consent through 12 months after last dose of MEDI1873
The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
From time of informed consent through 12 months after last dose of MEDI1873

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
Objective response rate (ORR)
Time Frame: Estimated to be from time of informed consent up to 4.5 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Estimated to be from time of informed consent up to 4.5 years
Disease control rate (DCR)
Time Frame: Estimated to be from time of informed consent up to 4.5 years
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
Estimated to be from time of informed consent up to 4.5 years
Duration of response (DoR)
Time Frame: Estimated to be from time of informed consent up to 4.5 years
Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Estimated to be from time of informed consent up to 4.5 years
Progression-free survival (PFS)
Time Frame: Estimated to be from time of informed consent up to 4.5 years
Progression-free survival will be measured from the start of treatment with MEDI1873 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Estimated to be from time of informed consent up to 4.5 years
Overall survival (OS)
Time Frame: Estimated to be from time of informed consent up to 4.5 years
Overall survival will be determined as the time from the start of treatment with MEDI1873 until death due to any cause.
Estimated to be from time of informed consent up to 4.5 years
Maximum observed concentration (Cmax) of MEDI1873
Time Frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
The immunogenicity of MEDI1873 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
PD biomarkers including changes from baseline levels in various lymphocyte populations
Time Frame: From time of informed consent through to disease progression, assessed up to 4.5 years
PD biomarkers including changes from baseline levels in various lymphocyte populations
From time of informed consent through to disease progression, assessed up to 4.5 years
Area under the curve (AUC) of MEDI1873
Time Frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Clearance (CL) of MEDI1873
Time Frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Terminal half-life of MEDI1873
Time Frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
From first dose of MEDI1873 through to 30 days after last dose of MEDI1873
Percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of MEDI1873 through to 12 months after last dose of MEDI1873
The immunogenicity of MEDI1873 will be assessed by summarizing the percentage of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of MEDI1873 through to 12 months after last dose of MEDI1873

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.
MedImmune LLC

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.
November 9, 2015

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.
December 19, 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.
December 19, 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).
October 19, 2015

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.
October 20, 2015

First Posted (Estimate)

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.
October 22, 2015

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.
January 8, 2019

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.
January 7, 2019

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.
January 1, 2019

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.
  • D6150C00001

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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