A Beta-only IL-2 ImmunoTherapY Study

Last updated: May 15, 2025
Sponsor: Medicenna Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Endometrial Cancer

Biliary Tract Cancer

Bladder Cancer

Treatment

Pembrolizumab (KEYTRUDA®)

MDNA11 Monotherapy

Pembrolizumab

Clinical Study ID

NCT05086692
MDNA11-01
2023-507536-21-00
MK3475-E53
KEYNOTE-E53
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anystudy procedures and assessments and must be willing to comply with all studyprocedures.

  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, (RECISTv1.1) 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 atscreening and within 72 hours before the first dose of study drug(s). Women must notbe breastfeeding.

  9. Agree to use highly effective contraception methods. WOCBP must agree to use highlyeffective birth control.

Exclusion

Key Exclusion Criteria:

  1. Last administration of prior antitumor therapy:
  • Prior systemic anti-cancer therapy including investigational agents within 4weeks (could consider shorter interval for kinase inhibitors or other shorthalf-life drugs) prior to start of treatment.

  • Prior radiotherapy within 2 weeks prior to start of treatment or has had ahistory of radiation pneumonitis. A 1-week washout is required for palliativeradiation (<2 weeks of radiotherapy) to non-CNS disease.

  • Radiation therapy to the lung that is > 30Gy within 6 months prior to start oftreatment.

  • Currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to start oftreatment. Concomitant participation in an observational study must bediscussed on a case-by-case basis with the MM for approval.

  1. Has known active CNS metastases and/or carcinomatous meningitis. Patients withpreviously treated brain metastases may participate provided they are radiologicallystable, 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 daysprior to start of treatment, subject to discussion with MM.

  2. Active malignancy (other than the disease under treatment in the study) within theprevious 3 years except for curable cancers.

  3. Condition requiring long-term systemic treatment with either corticosteroids > 10 mgdaily prednisone equivalent or any other form of immunosuppressive therapy within 7days prior to start of treatment.

  4. Clinically significant active, known or suspected autoimmune disease, or diseasesthat can be exacerbated with immunotherapy.

  5. Severe pulmonary, cardiac or other systemic disease.

  6. Known hepatitis B or C virus infection.

  7. Females who are pregnant or lactating or planning to become pregnant during thestudy.

  8. Has had an allogeneic tissue/solid organ transplant.

  9. Active infection requiring systemic therapy.

  10. Any medical, emotional or psychiatric condition that interfere with the patient'sability to adhere to the protocol

  11. Any other underlying medical conditions that, in the Investigator's opinion, willmake the administration of study drug(s) unsafe or obscure the interpretation oftoxicity determination or adverse events.

  12. Known severe hypersensitivity to any component of study drug(s).

  13. Inability to comply with study and follow up procedures as judged by theInvestigator.

Study Design

Total Participants: 115
Treatment Group(s): 5
Primary Treatment: Pembrolizumab (KEYTRUDA®)
Phase: 1/2
Study Start date:
August 27, 2021
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Scientia Clinical Research

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Macquarie University

    Sydney, New South Wales 2109
    Australia

    Active - Recruiting

  • University of the Sunshine Coast

    Buderim, Queensland 4556
    Australia

    Active - Recruiting

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland 4120
    Australia

    Active - Recruiting

  • ICON Cancer Center

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Cabrini Research

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M4W 3E2
    Canada

    Active - Recruiting

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea St. Vincent Hospital

    Suwon-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Jongno-gu
    Korea, Republic of

    Site Not Available

  • START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria

    Lisbon, 1649-035
    Portugal

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • START Barcelona / HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • START Madrid / Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrejon

    Torrejon, 28850
    Spain

    Active - Recruiting

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Active - Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Site Not Available

  • Providence Saint John's Health Center

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Emory - Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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