Engineered IL-2 drug tested against resistant cancers
NCT ID NCT05086692
First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time
Summary
Researchers are testing an engineered interleukin-2 drug called MDNA11 in adults with advanced solid tumors. The trial gives MDNA11 alone or with pembrolizumab, an immune checkpoint inhibitor, to see which doses are safe and how the body processes the drug. It also looks for early signs that tumors shrink. The study includes people with many cancer types, such as melanoma, kidney cancer, and triple-negative breast cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MDNA11, an engineered interleukin-2 (IL-2) drug, given alone or with pembrolizumab
- What this could lead to
- If it works, this could offer a new immunotherapy option for several advanced solid tumors, including some that resist current checkpoint inhibitors.
- What could go wrong
- This is an early-phase trial with about 160 participants, so it may not show clear benefit or could cause immune-related side effects. Results may not apply to all cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: 1. Aged at least 18 years (inclusive at the time of informed consent). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures. 4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions) 5. Demonstrated adequate organ function 6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI. 7. Life expectancy of ≥ 12 weeks. 8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding. 9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control. Key Exclusion Criteria: 1. Last administration of prior antitumor therapy: * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment. * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\<2 weeks of radiotherapy) to non-CNS disease. * Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment. * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval. 2. Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM. 3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers. 4. Condition requiring long-term systemic treatment with either corticosteroids \> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment. 5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy. 6. Severe pulmonary, cardiac or other systemic disease. 7. Known hepatitis B or C virus infection. 8. Females who are pregnant or lactating or planning to become pregnant during the study. 9. Has had an allogeneic tissue/solid organ transplant. 10. Active infection requiring systemic therapy. 11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol 12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events. 13. Known severe hypersensitivity to any component of study drug(s). 14. Inability to comply with study and follow up procedures as judged by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boca Raton Regional Hospital
ACTIVE_NOT_RECRUITINGBoca Raton, Florida, 33486, United States
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Emory - Winship Cancer Institute
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322, United States
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Gallipoli Medical Research Foundation
RECRUITINGGreenslopes, Queensland, 4120, Australia
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Hautkrebszentrum, Dermatologische Klinik Universitätsspital Zürich
RECRUITINGZurich, CH-8091, Switzerland
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Hospital Universitario Central de Asturias (HUCA)
WITHDRAWNOviedo, 33011, Spain
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Hospital Universitario Hm Sanchinarro
RECRUITINGMadrid, 28050, Spain
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitario de Torrejon
RECRUITINGTorrejón, 28850, Spain
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Hospital de la Santa Creu i Sant Pau
WITHDRAWNBarcelona, 08041, Spain
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Institut Catala d'Oncologia (ICO)-Badalona
RECRUITINGBadalona, 08916, Spain
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Instituto Portugues De Oncologia Do Porto
RECRUITINGPorto, 4200-072, Portugal
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Karmanos Cancer Institute
ACTIVE_NOT_RECRUITINGDetroit, Michigan, 48201, United States
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MD Anderson Cancer Center
ACTIVE_NOT_RECRUITINGHouston, Texas, 77030, United States
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Macquarie University
ACTIVE_NOT_RECRUITINGSydney, New South Wales, 2109, Australia
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Mater Misericordiae University Hospital
RECRUITINGDublin, D07 R2WY, Ireland
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Princess Margaret Cancer Center
ACTIVE_NOT_RECRUITINGToronto, Ontario, M4W 3E2, Canada
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Providence Saint John's Health Center
ACTIVE_NOT_RECRUITINGSanta Monica, California, 90404, United States
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START Barcelona / HM Nou Delfos
RECRUITINGBarcelona, 08023, Spain
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START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria
RECRUITINGLisbon, 1649-035, Portugal
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START Madrid / Hospital Universitario Fundacion Jimenez Diaz
RECRUITINGMadrid, 28040, Spain
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Samsung Medical Center
ACTIVE_NOT_RECRUITINGSeoul, Gangnam-gu, South Korea
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Scientia Clinical Research
ACTIVE_NOT_RECRUITINGRandwick, New South Wales, 2031, Australia
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Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITINGSeongnam-si, Gyeonggi-do, South Korea
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Seoul National University Hospital
ACTIVE_NOT_RECRUITINGSeoul, Jongno-gu, South Korea
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Sharp Memorial Hospital
ACTIVE_NOT_RECRUITINGSan Diego, California, 92123, United States
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The Catholic University of Korea St. Vincent Hospital
WITHDRAWNSuwon, Gyeonggi-do, South Korea
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UCSF Helen Diller Family Comprehensive Cancer Center
ACTIVE_NOT_RECRUITINGSan Francisco, California, 94158, United States
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University of the Sunshine Coast
ACTIVE_NOT_RECRUITINGBuderim, Queensland, 4556, Australia
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