A Beta-only IL-2 ImmunoTherapY Study

Study Purpose

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria


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 permitted 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medicenna Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nina MerchantMartin Bexon, MBBS
Principal Investigator Affiliation Medicenna TherapeuticsMedicenna Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Australia, Canada, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

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, Hepatocellular Carcinoma, 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
Additional Details

The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2. The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in multiple parts:

  • - Monotherapy (MDNA11 alone) dose escalation.
  • - Monotherapy (MDNA11 alone) dose expansion in select tumor types.
  • - Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types.
Approximately 115 patients will be enrolled. After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed at 12 weeks ± 1 week for the first scan and thereafter every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met. Patients can withdraw from participation at any time.

Arms & Interventions


Experimental: MDNA11

MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion


Drug: - MDNA11

MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the Recommended Dose for Expansion (RDE).

Drug: - Pembrolizumab

MDNA11 will be administered in combination with pembrolizumab, IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence Saint John's Health Center, Santa Monica, California




Providence Saint John's Health Center

Santa Monica, California, 90404

Boca Raton Regional Hospital, Boca Raton, Florida




Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Orlando Health Cancer Institute, Orlando, Florida




Orlando Health Cancer Institute

Orlando, Florida, 32806

Emory - Winship Cancer Institute, Atlanta, Georgia




Emory - Winship Cancer Institute

Atlanta, Georgia, 30322

International Sites

Scientia Clinical Research, Randwick, New South Wales, Australia




Scientia Clinical Research

Randwick, New South Wales, 2031

Macquarie University, Sydney, New South Wales, Australia




Macquarie University

Sydney, New South Wales, 2109

Gallipoli Medical Research Foundation, Greenslopes, Queensland, Australia




Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120

Princess Margaret Cancer Center, Toronto, Ontario, Canada




Princess Margaret Cancer Center

Toronto, Ontario, M4W 3E2

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