Clinical Trials /

MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

NCT02503774

Description:

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Subjects with Select Advanced Solid Tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
  • Official Title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: D6070C00001
  • NCT ID: NCT02503774

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
MEDI9447Monotherapy
MEDI9447 and MEDI4736Combination

Purpose

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Subjects with Select Advanced Solid Tumors

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalMEDI9447 (oleclumab) only
  • MEDI9447
CombinationExperimentalMEDI9447 (oleclumab) and MEDI4736 (durvalumab)
  • MEDI9447 and MEDI4736

Eligibility Criteria

        Inclusion Criteria:

          -  Adult subjects; age ≥ 18

          -  Written and signed informed consent must be obtained

          -  Have histologic or cytologic documentation of solid tumor including EGFR mutated
             (EGFRm) NSCLC

          -  Subjects must have at least 1 lesion that is measureable using RECIST guidelines

          -  Subjects must consent to provide archived tumor specimens or tumor biopsies for
             correlative biomarker studies.

          -  Eastern Cooperative Oncology Group performance score of 0 or 1

          -  Adequate organ function

        Exclusion Criteria:

          -  Prior treatment with tumor necrosis factor receptor superfamily agonists including
             OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, anti
             PDL-1 and anti PDL-1.

          -  Subjects who have received prior therapy with regimens containing CTLA-4, PD-L1, or
             PD-1 antagonists may be permitted to enroll under certain conditions

          -  Cardiac or peripheral vascular disease meeting any of the following criteria:

               -  Past history of myocardial infarction in the prior 12 months

               -  Past history of stroke or transient ischemic attack requiring medical therapy

               -  Congestive heart failure ≥ Class 3 based on New York Heart Association Functional
                  Classification

          -  Grade 3 or greater edema (eg, peripheral, pulmonary)

          -  History of Grade 3 or greater thromboembolic events in the prior 12 months

          -  Subjects with active tuberculosis are ineligible. In settings where there is clinical
             or radiographic evidence of tuberculosis, active disease must be ruled out

          -  Active or prior documented autoimmune or inflammatory disorders

          -  Untreated central nervous system (CNS) metastatic disease

          -  Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B
             or active hepatitis A or C

          -  Other invasive malignancy within 2 years except for noninvasive malignancies such as
             cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the
             skin, ductal carcinoma in situ of the breast that has been surgically cured

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, active peptic ulcer disease or gastritis, uncontrolled hypertension,
             uncontrolled diabetes, or psychiatric illness/social situations that would limit
             compliance with study requirement
      
Maximum Eligible Age:101 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events as a Measure of Safety
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issue:
Description:The primary endpoint is safety as assessed by the presence of AEs, serious adverse events (SAEs).

Secondary Outcome Measures

Measure:Composite measure of Preliminary antitumor activity
Time Frame:From the time of informed consent through an average of 1 year
Safety Issue:
Description:Assessment of antitumor activity include OR, disease control (DC), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
Measure:Composite measure of Pharmacokinetics of MEDI9447 or MEDI9447/MEDI4736
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issue:
Description:Including Cmax and AUC of MEDI9447 administered as a single agent and the Cmax and AUC of both MEDI9447 and MEDI4736 when administered in combination.
Measure:Composite measure of Immunogenicity
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issue:
Description:Immunogenicity of MEDI9447 and MEDI4736 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Measure:Biomarker activity
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issue:
Description:Assessment of target expression in subject samples.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:MedImmune LLC

Trial Keywords

  • Solid Tumors, MEDI9447, oleclumab, MEDI4736, durvalumab, CD73, PD-L1, EGFRm NSCLC, immunotherapy, pancreatic, colorectal

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