Boca Raton Regional Hospital | Lynn Clinical Research Center
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About
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.
Full description
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:
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 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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Last administration of prior antitumor therapy:
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.
Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
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.
Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
Severe pulmonary, cardiac or other systemic disease.
Known hepatitis B or C virus infection.
Females who are pregnant or lactating or planning to become pregnant during the study.
Has had an allogeneic tissue/solid organ transplant.
Active infection requiring systemic therapy.
Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
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.
Known severe hypersensitivity to any component of study drug(s).
Inability to comply with study and follow up procedures as judged by the Investigator.
Primary purpose
Allocation
Interventional model
Masking
115 participants in 1 patient group
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Central trial contact
Melissa Coello; Nina Merchant
Data sourced from clinicaltrials.gov
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