Atlanta, Georgia 30318

  • Solid Tumors

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


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


Study is Available At:


Original ID:

D6070C00001


NCT ID:

NCT02503774


Secondary ID:


Study Acronym:


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 Adv


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

101 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MedImmune LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

348


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:MedImmune LLC
Study Director
MedImmune LLC

Study Dates

Start Date:July 24, 2015
Completion Date:July 20, 2021
Completion Type:Anticipated
Primary Completion Date:July 20, 2021
Primary Completion Type:Anticipated
Verification Date:January 2020
Last Changed Date:January 3, 2020
First Received Date:July 6, 2015

Study Outcomes

Outcome Type:Primary Outcome
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 Issues:False
Description:The primary endpoint is safety as assessed by the presence of AEs, serious adverse events (SAEs).
Outcome Type:Secondary Outcome
Measure:Composite measure of Preliminary antitumor activity
Time Frame:From the time of informed consent through an average of 1 year
Safety Issues:False
Description:Assessment of antitumor activity include OR, disease control (DC), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
Outcome Type:Secondary Outcome
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 Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Composite measure of Immunogenicity
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issues:False
Description:Immunogenicity of MEDI9447 and MEDI4736 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Outcome Type:Secondary Outcome
Measure:Biomarker activity
Time Frame:From time of informed consent through 12 weeks after last dose of investigational product
Safety Issues:False
Description:Assessment of target expression in subject samples.

Study Interventions

Intervention Type:Biological
Name:MEDI9447
Description:Subjects will receive MEDI9447 until disease progression
Arm Name:Monotherapy
Intervention Type:Biological
Name:MEDI9447 and MEDI4736
Description:Subjects will receive MEDI9447 and MEDI4736 until disease progression
Arm Name:Combination

Study Arms

Study Arm Type:Experimental
Arm Name:Monotherapy
Description:MEDI9447 (oleclumab) only
Study Arm Type:Experimental
Arm Name:Combination
Description:MEDI9447 (oleclumab) and MEDI4736 (durvalumab)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MedImmune LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.