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Completed

NCT Number: NCT02583165

A Study in Adult Subjects With Select Advanced Solid Tumors

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Phoenix, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MEDI1873

Biological

Subjects will receive MEDI1873 by intravenous administration

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2015
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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