A Beta-only IL-2 ImmunoTherapY Study

Launched by MEDICENNA THERAPEUTICS, INC. · Oct 7, 2021

Keywords

ClinConnect Summary

This clinical trial, called the Beta-only IL-2 ImmunoTherapY Study, is looking to test a new treatment called MDNA11 for patients with advanced solid tumors, which are types of cancer that have spread and cannot be surgically removed. The trial aims to understand how safe the treatment is, how well it works, and how the body processes it when used alone or with another cancer treatment known as a checkpoint inhibitor. It is currently recruiting participants aged 18 and older, who have specific types of cancers such as bladder cancer, lung cancer, or colorectal cancer, among others.

To be eligible for the trial, participants must be generally healthy, have a measurable tumor, and expect to live at least 12 weeks. They should not have received certain cancer treatments recently or have other serious health conditions that might interfere with the study. If someone joins the trial, they can expect to undergo regular assessments to monitor their health and the effects of the treatment. It's important for potential participants to understand that this is an early-stage trial, meaning it is still testing how well the treatment works and observing any side effects.

Gender

ALL

Eligibility 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.