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A Beta-only IL-2 ImmunoTherapY Study
Sponsor: Medicenna Therapeutics, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2021-08-27
Completion Date
2026-12-30
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
MDNA11
MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).
Pembrolizumab (KEYTRUDA®)
MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).
Locations (27)
Sharp Memorial Hospital
San Diego, California, United States
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
Emory - Winship Cancer Institute
Atlanta, Georgia, 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
University of the Sunshine Coast
Buderim, Queensland, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Mater Misericordiae University Hospital
Dublin, Ireland
START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
Lisbon, Portugal
Instituto Portugues De Oncologia Do Porto
Porto, 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, Spain
START Barcelona / HM Nou Delfos
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
Hospital Universitario de Torrejon
Torrejón, Spain