We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 19, 2015
First Posted Date  ICMJE October 22, 2015
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE November 9, 2015
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI1873 [ Time Frame: From first dose of MEDI1873 through to 30 days after last dose of MEDI1873 ]
    The endpoints for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration
  • Number and 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 number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Adult Subjects With Select Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors
Brief Summary To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Biological: MEDI1873
Subjects will receive MEDI1873 by intravenous administration
Study Arms  ICMJE Experimental: Monotherapy arm
MEDI1873
Intervention: Biological: MEDI1873
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
42
Actual Study Completion Date  ICMJE December 19, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Spain
 
Administrative Information
NCT Number  ICMJE NCT02583165
Other Study ID Numbers  ICMJE D6150C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MedImmune LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MedImmune LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medimmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP