A Beta-only IL-2 ImmunoTherapY (ABILITY) Study
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- STATUS
- Recruiting
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- End date
- Dec 30, 2024
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- participants needed
- 100
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- sponsor
- Medicenna Therapeutics, Inc.
Summary
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.
Description
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.
Approximately 100 patients will be enrolled.
Tumor assessment by CT/MRI will be performed every 12 weeks and will continue until documented disease progression. Treatment may continue for up to 1 year, or until treatment discontinuation criteria are met. Patients can withdraw from participation at any time.
Details
| Condition | 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 |
|---|---|
| Treatment | MDNA11 Monotherapy, MDNA11 in combination with checkpoint inhibitor |
| Clinical Study Identifier | NCT05086692 |
| Sponsor | Medicenna Therapeutics, Inc. |
| Last Modified on | 4 October 2022 |
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