Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|
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 that is unresectable (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 or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter. Palliative radiotherapy given within 28 days prior to the first dose of study drug may be approved on a case-by-case basis in discussion with the Sponsor. 2. Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases permitted based on Medical Monitor review. 3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers. 4. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy. 5. Severe pulmonary, cardiac or other systemic disease. 6. Females who are pregnant or lactating or planning to become pregnant during the study. 7. Active infection requiring systemic therapy. 8. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol. 9. 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. 10. Known severe hypersensitivity to any component of study drug(s). 11. Prior Interleukin therapy. 12. Inability to comply with study and follow up procedures as judged by the Investigator.
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|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Medicenna Therapeutics, Inc.|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Canada, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Advanced Solid Tumor, Unresectable Solid Tumor, Melanoma, Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer Squamous, Non-Small Cell Lung Cancer Non-squamous, Colorectal Cancer, Gastric Cancer, Biliary Tract Cancer, Gallbladder 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|
The study drug, MDNA11, is a selective IL-2 preferentially activating effector T cells (naïve CD8+ T-cells) and NK cells responsible for killing cancer cells, with minimal or no stimulation of the 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 16 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 two parts:
- - Sequential Dose Escalation.
- - Dose Expansion in monotherapy as well as with an immune checkpoint inhibitor.
MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion
Drug: - MDNA11 Monotherapy
MDNA11 will be administered by the IV route 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 Phase 2 Dose (RP2D)
Drug: - MDNA11 in combination with checkpoint inhibitor
MDNA11 in combination with checkpoint inhibitor Combination cohort is planned to evaluate the safety/ tolerability and anti-tumor activity of single agent MDNA11, or in combination with CPI in patients with solid tumors
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.