Actively Recruiting
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
Led by Medicenna Therapeutics, Inc. · Updated on 2025-07-09
115
Participants Needed
27
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Medicenna Therapeutics, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts: dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11's effects alone and with pembrolizumab.
CONDITIONS
Brief Title
A Beta-only IL-2 ImmunoTherapY Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Able and willing to provide written informed consent and comply with study procedures
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
- Adequate organ function
- Measurable disease by RECIST v1.1 documented by CT and/or MRI
- Life expectancy of at least 12 weeks
- Women of childbearing potential must have negative pregnancy test within 72 hours before first dose and agree to use effective contraception
- Women must not be breastfeeding
You will not qualify if you...
- Received systemic anti-cancer therapy or investigational agents within 4 weeks before treatment
- Radiotherapy within 2 weeks before treatment or history of radiation pneumonitis; 1-week washout for palliative radiation
- Radiation therapy to lung exceeding 30Gy within 6 months before treatment
- Participation in another investigational study or device use within 4 weeks before treatment
- Known active CNS metastases or carcinomatous meningitis unless stable and off steroids for at least 14 days
- Active malignancy other than study disease within 3 years except curable cancers
- Long-term systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressive therapy within 7 days before treatment
- Active or suspected autoimmune disease that may worsen with immunotherapy
- Severe pulmonary, cardiac, or other systemic disease
- Known hepatitis B or C infection
- Pregnant, lactating, or planning pregnancy during study
- History of allogeneic tissue or solid organ transplant
- Active infection needing systemic therapy
- Medical, emotional, or psychiatric conditions interfering with protocol adherence
- Other medical conditions contraindicating study drug use or safety
- Known severe hypersensitivity to study drug components
- Inability to comply with study and follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive MDNA11 intravenously every 2 weeks, either alone or in combination with pembrolizumab. Treatment continues until disease progression, unacceptable side effects, withdrawal of consent, or loss to follow-up.
IV dosing every 2 weeks with tumor assessments every 8 weeks
Duration - Up to 24 months
Participants are monitored for safety and long-term effects after stopping treatment.
Regular follow-up visits during this period
Trial Site Locations
Total: 27 locations
1
Sharp Memorial Hospital
San Diego, California, United States, 92123
Actively Recruiting
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Active, Not Recruiting
3
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
4
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Actively Recruiting
5
Emory - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
8
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
9
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
10
University of the Sunshine Coast
Buderim, Queensland, Australia, 4556
Actively Recruiting
11
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
12
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M4W 3E2
Actively Recruiting
13
Mater Misericordiae University Hospital
Dublin, Ireland, D07 R2WY
Actively Recruiting
14
START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
15
Instituto Portugues De Oncologia Do Porto
Porto, Portugal, 4200-072
Actively Recruiting
16
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Active, Not Recruiting
17
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Active, Not Recruiting
18
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Active, Not Recruiting
19
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Active, Not Recruiting
20
Institut Catala d'Oncologia (ICO)-Badalona
Badalona, Spain, 08916
Actively Recruiting
21
START Barcelona / HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
22
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
23
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
24
START Madrid / Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
25
Hospital Universitario Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
26
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain, 33011
Actively Recruiting
27
Hospital Universitario de Torrejon
Torrejón, Spain, 28850
Actively Recruiting
Research Team
N
Nina Merchant
M
Melissa Coello
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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