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

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ClinicalTrials.gov Identifier: NCT02318394
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: MEDI0562 Phase 1

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  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018

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.




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 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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

  5. 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)

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02318394


Locations
United States, California
Research Site
La Jolla, California, United States, 92093
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
Research Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55404
United States, New York
Research Site
Bronx, New York, United States, 10461
Research Site
New York, New York, United States, 10032
United States, North Carolina
Research Site
Huntersville, North Carolina, United States, 28078
United States, Oregon
Research Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Research Site
Dallas, Texas, United States, 75201
Research Site
Houston, Texas, United States, 77005
Korea, Republic of
Research Site
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Medimmune LLC MedImmune LLC

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02318394     History of Changes
Other Study ID Numbers: D6060C00001
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by MedImmune LLC:
advanced solid tumors; immunotherapy; OX40; immuno-oncology