What is MDNA11 studying for advanced solid tumors?

MDNA11 is being studied to understand its safety, how it behaves in the body, and its early effects on advanced solid tumors when given alone or with pembrolizumab. This research aims to evaluate a new way to activate the immune system to fight cancer, supported by Medicenna Therapeutics, Inc.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 or older with confirmed advanced or metastatic solid tumors may be eligible. Participants need a good general health status and measurable disease. Both men and women can join, but women of childbearing potential must meet pregnancy and contraception requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID05086692

A Phase 12 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

Research Sites

26 weeks

Total Duration

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 12 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 MDNA11s effects alone and with pembrolizumab.

CONDITIONS

Brief Title

A Beta-only IL-2 ImmunoTherapY Study

Who Can Participate

Age: 18Years +

All Genders

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

Research Team

Nina Merchant

Melissa Coello

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