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MDNA11 for Advanced Solid Tumors

This study is testing a new treatment called MDNA11, alone or with pembrolizumab (KEYTRUDA®), for advanced solid tumors, including clear cell renal cell carcinoma, triple negative breast cancer, and non-small cell lung cancer squamous. MDNA11 is designed to boost your body's immune system to fight cancer. Researchers want to find the safest and most effective dose of MDNA11, both by itself and when combined with pembrolizumab. They will also look for early signs that the treatment is working against the cancer. You may be eligible to join if you are at least 18 years old and have an advanced solid tumor. The study aims to enroll about 115 participants.

Study design
This is a Phase 1/2, multi-center, open-label study with about 115 participants. It involves increasing doses of MDNA11 alone, and then MDNA11 combined with pembrolizumab.
What's involved
After starting treatment, tumor assessments will be done every 8 weeks until your disease progresses, you stop treatment, or you withdraw from the study.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like recommended doses and side effects for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05086692

A Beta-only IL-2 ImmunoTherapY Study

Recruiting
PHASE1Ages 18+InterventionalTreatment
Medicenna Therapeutics, Inc.
~115 participants
Updated 2025-07-09 on ClinicalTrials.gov
What's tested:MDNA11Pembrolizumab (KEYTRUDA®)

At a glance

Recruiting sites
21 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)
Measured over 24 months
+2 more outcomes measured

Conditions

Advanced Solid Tumor
Unresectable Solid Tumor
Clear Cell Renal Cell Carcinoma
Triple Negative Breast Cancer
Non-Small Cell Lung Cancer Squamous
Non-Small Cell Lung Cancer Non-squamous
Colorectal Cancer (MSI-H)
Gastric Cancer
Cervical Cancer
Basal Cell Carcinoma
Bladder Cancer
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma
Pleural Mesothelioma
Esophageal Cancer
Endometrial Carcinoma
Solid Tumor
Solid Tumor, Adult
MSI-H Solid Malignant Tumor
Cancer With A High Tumor Mutational Burden
Epithelial Ovarian Carcinoma
Primary Peritoneal Cancer
Gastroesophageal Junction (GEJ) Cancer
Acral Melanoma
Mucosal Melanoma
Cutaneous Melanoma
DMMR Solid Malignant Tumor
Fallopian Tube Cancer
Ovarian Cancer
MSI-H Cancer
DMMR Cancer
Pancreas Adenocarcinoma (MSI-H)
Skin Cancer
Viral Cancer
Cervical Cancers
Endometrial Cancer

Explore related trials

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Where it's being run

27 sites across 14 states
Spain8
California3
New South Wales2
Queensland2
Portugal2
Gyeonggi-do2
Florida1
Georgia1

Study leadership

  • Nina Merchant · STUDY_DIRECTOR · Medicenna Therapeutics
  • Arash Yavari, MBBS · STUDY_CHAIR · Medicenna Therapeutics

Who to contact

Nina Merchant
[email protected]
604-340-3081
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)24 months

    Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

  • Incidence of Treatment Related Adverse Events (TRAEs)24 months

    Rate of TRAEs in patients with advanced solid tumors

  • Incidence of Treatment Emergent Adverse Events (TEAEs)24 months

    Rate of TEAEs in patients with advanced solid tumors