Spots Global Cancer Trial Database for A Beta-only IL-2 ImmunoTherapY Study
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Trial Identification
Brief Title: A Beta-only IL-2 ImmunoTherapY Study
Official Title: A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors
Study ID: NCT05086692
Conditions
Study Description
Brief Summary: This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.
Detailed Description: The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2. The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in multiple parts: * Monotherapy (MDNA11 alone) dose escalation * Monotherapy (MDNA11 alone) dose expansion in select tumor types * Combination (MDNA11 + pembrolizumab) dose escalation * Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types Approximately 115 patients will be enrolled. After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met. Patients can withdraw from participation at any time.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Providence Saint John's Health Center, Santa Monica, California, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Emory - Winship Cancer Institute, Atlanta, Georgia, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
MD Anderson Cancer Center, Houston, Texas, United States
Scientia Clinical Research, Randwick, New South Wales, Australia
Macquarie University, Sydney, New South Wales, Australia
Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Samsung Medical Center, Seoul, Gangnam-gu, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of
Contact Details
Name: Nina Merchant
Affiliation: Medicenna Therapeutics
Role: STUDY_DIRECTOR
Name: Martin Bexon, MBBS
Affiliation: Medicenna Therapeutics
Role: STUDY_CHAIR
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