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

Sponsor
MedImmune LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02503774
Collaborator
(none)
190
Enrollment
18
Locations
2
Arms
89.9
Anticipated Duration (Months)
10.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: MEDI9447
  • Biological: MEDI9447 and MEDI4736
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 24, 2015
Actual Primary Completion Date :
Jan 22, 2021
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monotherapy

MEDI9447 (oleclumab) only

Biological: MEDI9447
Subjects will receive MEDI9447 until disease progression
Experimental: Combination

MEDI9447 (oleclumab) and MEDI4736 (durvalumab)

Biological: MEDI9447 and MEDI4736
Subjects will receive MEDI9447 and MEDI4736 until disease progression

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Events as a Measure of Safety [From time of informed consent through 12 weeks after last dose of investigational product]

    The primary endpoint is safety as assessed by the presence of AEs, serious adverse events (SAEs).

Secondary Outcome Measures

  1. Composite measure of Preliminary antitumor activity [From the time of informed consent through an average of 1 year]

    Assessment of antitumor activity include OR, disease control (DC), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).

  2. Composite measure of Pharmacokinetics of MEDI9447 or MEDI9447/MEDI4736 [From time of informed consent through 12 weeks after last dose of investigational product]

    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.

  3. Composite measure of Immunogenicity [From time of informed consent through 12 weeks after last dose of investigational product]

    Immunogenicity of MEDI9447 and MEDI4736 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).

  4. Biomarker activity [From time of informed consent through 12 weeks after last dose of investigational product]

    Assessment of target expression in subject samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 101 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site La Jolla California United States 92093
2 Research Site New Haven Connecticut United States 06510
3 Research Site Gainesville Florida United States 32610
4 Research Site Atlanta Georgia United States 30318
5 Research Site Saint Louis Missouri United States 63156
6 Research Site Durham North Carolina United States 27705
7 Research Site Cincinnati Ohio United States 45267
8 Research Site Columbus Ohio United States 43210
9 Research Site Nashville Tennessee United States 37203
10 Research Site Dallas Texas United States 75230
11 Research Site Houston Texas United States 77030
12 Research Site Camperdown Australia 2050
13 Research Site Parkville Australia 3050
14 Research Site St Leonards Australia 2065
15 Research Site Woolloongabba Australia 4068
16 Research Site Seoul Korea, Republic of 03080
17 Research Site Seoul Korea, Republic of 05505
18 Research Site Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • MedImmune LLC

Investigators

  • Study Director: MedImmune LLC, MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02503774
Other Study ID Numbers:
  • D6070C00001
First Posted:
Jul 21, 2015
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MedImmune LLC
Solid Tumors, MEDI9447, oleclumab, MEDI4736, durvalumab, CD73, PD-L1, EGFRm NSCLC, immunotherapy, pancreatic, colorectal
Additional relevant MeSH terms:
Neoplasms
Durvalumab

Study Results

No Results Posted as of Jul 20, 2022