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Beta-only IL-2 treatment for advanced solid tumors

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

PHASE1; PHASE2 · Medicenna Therapeutics, Inc. · NCT05086692

This study is testing a new treatment called MDNA11 to see if it can help people with advanced solid tumors by boosting their immune response while causing fewer side effects.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment115 (estimated)
Ages18 Years and up
SexAll
SponsorMedicenna Therapeutics, Inc. (industry)
Drugs / interventionsimmunotherapy, radiation, prednisone, pembrolizumab
Locations27 sites (San Diego, California and 26 other locations)
Trial IDNCT05086692 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 clinical trial evaluates the safety and effectiveness of MDNA11, a long-acting 'beta-only' interleukin-2, in patients with advanced solid tumors. The study involves dose escalation and expansion phases, both for MDNA11 alone and in combination with pembrolizumab, a checkpoint inhibitor. Patients will undergo regular tumor assessments to monitor treatment response and safety. The trial aims to enhance the immune response against cancer while minimizing side effects associated with traditional IL-2 therapies.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors who have a good performance status and measurable disease.

Not a fit: Patients with early-stage tumors or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, more effective option for patients with advanced solid tumors.

How similar studies have performed: Other studies using similar immunotherapy approaches have shown promising results, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

San Diego, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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, Gastric Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.