A Beta-only IL-2 ImmunoTherapY Study
Start Date
8/27/2021
Completion Date
12/30/2026
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 Criteria
Age Range: 18 years to No maximum
Interventions
MDNA11
Pembrolizumab (KEYTRUDA®)
Conditions
Locations
Sharp Memorial Hospital
San Diego, California 92123
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Providence Saint John's Health Center
Santa Monica, California 90404
United States
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Emory - Winship Cancer Institute
Atlanta, Georgia 30322
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Scientia Clinical Research
Randwick, New South Wales 2031
Australia
Macquarie University
Sydney, New South Wales 2109
Australia
University of the Sunshine Coast
Buderim, Queensland 4556
Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
Australia
Princess Margaret Cancer Center
Toronto, Ontario M4W 3E2
Canada
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Ireland
START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
Lisbon, 1649-035
Portugal
Instituto Portugues De Oncologia Do Porto
Porto, 4200-072
Portugal
Samsung Medical Center
Seoul, Gangnam-gu
South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
South Korea
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do
South Korea
Seoul National University Hospital
Seoul, Jongno-gu
South Korea
Institut Catala d'Oncologia (ICO)-Badalona
Badalona, 08916
Spain
START Barcelona / HM Nou Delfos
Barcelona, 08023
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario Hm Sanchinarro
Madrid, 28050
Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, 33011
Spain
Hospital Universitario de Torrejon
Torrejón, 28850
Spain