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Clinical Trial 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.


Clinical Trial 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: - Monotherapy (MDNA11 alone) dose escalation - Monotherapy (MDNA11 alone) dose expansion in select tumor types - Combination (MDNA11 + pembrolizumab) dose escalation - 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Acral Melanoma
  • Advanced Solid Tumor
  • Basal Cell Carcinoma
  • Bladder Cancer
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Merkel Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Cervical Cancer
  • Clear Cell Renal Cell Carcinoma
  • Cutaneous Melanoma
  • Cutaneous Squamous Cell Carcinoma
  • Endometrial Carcinoma
  • Endometrial Neoplasms
  • Epithelial Ovarian Carcinoma
  • Esophageal Cancer
  • Fallopian Tube Cancer
  • Fallopian Tube Neoplasms
  • Gastric Cancer
  • Lung Neoplasms
  • Melanoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • MSI-H Solid Malignant Tumor
  • Mucosal Melanoma
  • Neoplasms
  • Ovarian Cancer
  • Pleural Mesothelioma
  • Primary Peritoneal Cancer
  • Skin Cancer
  • Solid Tumor
  • Solid Tumor, Adult
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms

NCT number NCT05086692
Study type Interventional
Source Medicenna Therapeutics, Inc.
Contact Nina Merchant
Phone 604-340-3081
Email nmerchant@medicenna.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 27, 2021
Completion date December 30, 2026

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