MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.
NCT ID: NCT02503774
Last Updated: 2023-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
192 participants
INTERVENTIONAL
2015-07-24
2023-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase I Study of MEDI9447 (Oleclumab) in Japanese Patients
NCT03736473
Phase I Study of AZD5363 + Olaparib + Durvalumab in Patients With Advanced or Metastatic Solid Tumor Malignancies
NCT03772561
Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations
NCT03842228
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors
NCT03811652
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
NCT04261075
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose-escalation: Oleclumab Dose 1
Participants will receive oleclumab Dose 1 intravenously (IV) every two weeks (Q2W) until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Dose-escalation: Oleclumab Dose 2
Participants will receive oleclumab Dose 2 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Dose-escalation: Oleclumab Dose 3
Participants will receive oleclumab Dose 3 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Dose-escalation: Oleclumab Dose 4
Participants will receive oleclumab Dose 4 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Dose-escalation: Oleclumab Dose 1 + Durvalumab Dose 1
Participants will receive oleclumab Dose 1 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-escalation: Oleclumab Dose 2 + Durvalumab Dose 1
Participants will receive oleclumab Dose 2 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-escalation: OleclumabDose 3 + Durvalumab Dose 1
Participants will receive oleclumab Dose 3 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-escalation: OleclumabDose 4 + Durvalumab Dose 1
Participants will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-expansion (CRC): Oleclumab Dose 4 + Durvalumab Dose 1
Participants with previously treated microsatellite stable-colorectal cancer (MSS-CRC) will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-expansion (Pancreatic adenocarcinoma): Oleclumab Dose 4+ Durvalumab Dose 1
Participants with previously treated pancreatic adenocarcinoma will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Dose-expansion (NSCLC): Oleclumab Dose 4 + Durvalumab Dose 1
Participants with previously treated EGFRm NSCLC will receive oleclumab Dose 4 IV followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arms' description.
Durvalumab
Participants will receive IV infusion of durvalumab as stated in arms' description.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written and signed informed consent must be obtained
* Have histologic or cytologic documentation of solid tumor including EGFRm NSCLC
* Participants must have at least 1 lesion that is measurable using RECIST guidelines
* Participants 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
* Participants 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
* Participants 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
18 Years
101 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
La Jolla, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Gainesville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
St Louis, Missouri, United States
Research Site
Durham, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Camperdown, , Australia
Research Site
Parkville, , Australia
Research Site
St Leonards, , Australia
Research Site
Woolloongabba, , Australia
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bendell J, LoRusso P, Overman M, Noonan AM, Kim DW, Strickler JH, Kim SW, Clarke S, George TJ, Grimison PS, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan AA, Wu Y, Martin P, Cooper ZA, Elgeioushi N, Mueller N, Kumar R, Patel SP. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunol Immunother. 2023 Jul;72(7):2443-2458. doi: 10.1007/s00262-023-03430-6. Epub 2023 Apr 5.
Hay CM, Sult E, Huang Q, Mulgrew K, Fuhrmann SR, McGlinchey KA, Hammond SA, Rothstein R, Rios-Doria J, Poon E, Holoweckyj N, Durham NM, Leow CC, Diedrich G, Damschroder M, Herbst R, Hollingsworth RE, Sachsenmeier KF. Targeting CD73 in the tumor microenvironment with MEDI9447. Oncoimmunology. 2016 Jul 11;5(8):e1208875. doi: 10.1080/2162402X.2016.1208875. eCollection 2016 Aug.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D6070C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.