A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

January 26, 2018 updated by: MedImmune LLC

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • 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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Research Site
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • Research Site
      • New York, New York, United States, 10032
        • Research Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75201
        • Research Site
      • Houston, Texas, United States, 77005
        • 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

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
  • Subjects must have at least 1 measurable lesion.
  • Consent to provide archived tumor specimens
  • Willingness to undergo pre-treatment and on-treatment biopsy.
  • Adequate organ function.
  • Use of highly effective contraception (females) or male condom plus spermicide (males).

Exclusion Criteria:

  • Prior treatment with TNFRSF agonists.

  • Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.

    o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.

  • History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
  • Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
  • Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Arm
MEDI0562 monotherapy
Biological: MEDI0562
Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.

What is the study measuring?

Primary Outcome Measures

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 weeks after last dose of MEDI0562
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
From time of informed consent through 12 weeks after last dose of MEDI0562

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Estimated to be from time of informed consent up to 5 years
The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR
Estimated to be from time of informed consent up to 5 years
Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
Time Frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.
From first dose of MEDI0562 through to 30 days after last dose of investigational product
Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of MEDI0562 through to 30 days after last dose of investigational product
The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of MEDI0562 through to 30 days after last dose of investigational product
Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
Time Frame: From time of informed consent through 12 weeks after last dose of investigational product
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphoctye subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
From time of informed consent through 12 weeks after last dose of investigational product
Disease control rate (DCR)
Time Frame: Estimated to be from time of informed consent up to 5 years
The DCR is defined as the proportion of subjects with irCR, irPR, or irSD (subjects achieving irSD will be included in the DCR if they maintain irSD for ≥8 weeks)
Estimated to be from time of informed consent up to 5 years
Duration of response (DoR)
Time Frame: Estimated to be from time of informed consent up to 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 5 years
Progression-free survival (PFS)
Time Frame: Estimated to be from time of informed consent up to 5 years
Progression-free survival will be measured from the start of treatment with MEDI0562 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
Estimated to be from time of informed consent up to 5 years
Overall survival (OS)
Time Frame: Estimated to be from time of informed consent up to 5 years
Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.
Estimated to be from time of informed consent up to 5 years

Collaborators and Investigators

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

Sponsor

MedImmune LLC

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)

March 2, 2015

Primary Completion (Actual)

January 9, 2018

Study Completion (Actual)

January 9, 2018

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6060C00001

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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