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A Study in Adult Subjects With Select Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583165
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: MEDI1873 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
Actual Study Start Date : November 9, 2015
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Arm Intervention/treatment
Experimental: Monotherapy arm
MEDI1873
Biological: MEDI1873
Subjects will receive MEDI1873 by intravenous administration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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)



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02583165


Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States, 85054
Research Site
Scottsdale, Arizona, United States, 85258
United States, California
Research Site
Los Angeles, California, United States, 90025
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, New York
Research Site
New York, New York, United States, 10032
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73117
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Houston, Texas, United States, 77521
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: Medimmune LLC MedImmune LLC
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02583165    
Other Study ID Numbers: D6150C00001
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Keywords provided by MedImmune LLC:
advanced solid tumors
immunotherapy
immuno-oncology
Additional relevant MeSH terms:
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Neoplasms