Study on Beta-only IL-2 Immunotherapy for Advanced Solid Tumors

Sponsor: Medicenna Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05086692

Provider View

This clinical trial is testing a new treatment called MDNA11, which is designed to boost the immune system's ability to fight cancer. The study will explore the safety and effectiveness of MDNA11 alone and in combination with another drug, pembrolizumab, in adults with advanced solid tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug, MDNA11, which is a long-acting form of interleukin-2 (IL-2) designed to enhance the immune system's ability to attack cancer cells. The study will test MDNA11 alone and in combination with a checkpoint inhibitor, pembrolizumab, in patients with advanced solid tumors. The trial will take place at multiple locations and will involve different phases to determine the best dose and treatment approach.

Description

This study involves a new drug called MDNA11, which is a specially designed version of interleukin-2 (IL-2) that aims to improve the immune system's ability to fight cancer. MDNA11 works by activating certain immune cells that target and kill cancer cells, while minimizing the activation of cells that suppress the immune response. The drug is designed to last longer in the body, reducing the need for frequent dosing.

The study will be conducted at up to 30 clinical sites and will include several parts:

  • Testing different doses of MDNA11 alone to find the safest and most effective dose.
  • Expanding the study to include more patients with specific types of tumors to further evaluate MDNA11 alone.
  • Testing different doses of MDNA11 in combination with pembrolizumab, a drug that helps the immune system attack cancer.
  • Expanding the study to include more patients with specific types of tumors to further evaluate the combination of MDNA11 and pembrolizumab.

Approximately 115 patients will participate in the study. After starting treatment, patients will have their tumors assessed by scans every 8 weeks to monitor the response. Patients can continue treatment beyond initial progression if certain criteria are met, and they can choose to leave the study at any time.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Able and willing to provide written consent and comply with study procedures.
  • Have a confirmed diagnosis of locally advanced or metastatic solid tumor.
  • Have adequate organ function as determined by medical tests.
  • Have measurable disease as shown by scans.
  • Have a life expectancy of at least 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test and not be breastfeeding.
  • Agree to use effective birth control methods.

Exclusion Criteria

  • Have received prior cancer treatment within a specified time before starting the study.
  • Have active cancer that has spread to the brain or spinal cord, unless stable and not requiring steroids.
  • Have another active cancer within the past 3 years, except for certain curable cancers.
  • Require long-term treatment with steroids or other immunosuppressive drugs.
  • Have significant autoimmune diseases or conditions worsened by immunotherapy.
  • Have severe lung, heart, or other systemic diseases.
  • Have active hepatitis B or C infections.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have had a tissue or organ transplant.
  • Have an active infection requiring treatment.
  • Have any medical or psychiatric conditions that interfere with study participation.
  • Have severe allergies to study drugs.
  • Unable to comply with study procedures.

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