A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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Active drug More information Moderate burden on patient More information Started >3 years ago More information

Trial Details

Sponsor: Medicenna Therapeutics, Inc. (industry)

Phase: 1/2

Start date: Aug. 27, 2021

Planned enrollment: 115

Trial ID: NCT05086692
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More trial details at ClinicalTrials.gov More info

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chevron Show for: MDNA11 (MDNA109FEAA)

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Goal: Evaluate the safety, tolerability, recommended doses for expansion, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of MDNA11, a long-acting IL-2 beta-only superkine, administered as monotherapy or in combination with pembrolizumab in advanced solid tumors.

Patients: Adults (≥18 years) with histologically or cytologically confirmed locally advanced or metastatic solid tumors, ECOG 0–1, measurable disease by RECIST v1.1, adequate organ function, and life expectancy ≥12 weeks. Key exclusions include active CNS metastases (unless treated and stable), recent systemic therapy or radiotherapy, significant autoimmune disease or need for immunosuppression, severe cardiopulmonary disease, active infections including HBV/HCV, prior allogeneic transplant, and pregnancy or lactation.

Design: Phase 1/2, multi-center, open-label, non-randomized dose-escalation and expansion study with four parts: MDNA11 monotherapy dose escalation, monotherapy expansion in select tumor types, MDNA11 plus pembrolizumab dose escalation, and combination expansion. Tumor assessments by CT/MRI every 8 weeks using RECIST v1.1 and iRECIST, with treatment beyond progression allowed per protocol criteria.

Treatments: MDNA11 as monotherapy and in combination with pembrolizumab. MDNA11 is an engineered interleukin-2 superkine (MDNA109FEAA) fused to human albumin to extend half-life and designed to preferentially bind IL-2Rβ while avoiding IL-2Rα, thereby activating effector CD8+ T cells and NK cells with minimal Treg stimulation. Early clinical data from the ongoing program have shown signals of activity, including responses in checkpoint inhibitor–refractory populations, and a favorable safety profile without dose-limiting toxicities up to 120 μg/kg; most adverse events have been grade 1–2 and transient. The combination with pembrolizumab has produced early responses in select tumor types, supporting biological synergy with checkpoint blockade. Pembrolizumab is a PD-1 inhibitor used as standard immunotherapy across multiple solid tumors.

Outcomes: Primary: determination of recommended doses for expansion for monotherapy and combination based on dose-limiting toxicities; incidence of treatment-related and treatment-emergent adverse events. Secondary: pharmacokinetics of MDNA11 (Cmax, Tmax, AUClast), immunogenicity (anti-drug antibodies), pharmacodynamics (circulating immune cell subsets and cytokines), and anti-tumor activity by RECIST v1.1 and iRECIST including ORR, DCR, and PFS. Other: changes in tumor microenvironment immune characteristics, including tumor-infiltrating lymphocytes.

Burden on patient: High. As an early-phase dose-escalation/expansion study with both monotherapy and combination cohorts, patients should anticipate frequent clinic visits, intensive safety monitoring, and serial PK and PD blood draws, particularly around dosing days. Imaging is scheduled every 8 weeks, and optional or mandated tumor biopsies for translational analyses may be requested, adding procedural burden. Travel demands may be substantial due to the visit frequency typical of phase 1/2 immunotherapy trials and potential infusion-related monitoring periods.

Last updated: Oct 2025

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Sites (27)

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Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

No email / No phone

Status: Recruiting

Macquarie University

Sydney, New South Wales, 2109, Australia

No email / No phone

Status: Recruiting

Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120, Australia

No email / No phone

Status: Recruiting

University of the Sunshine Coast

Buderim, Queensland, 4556, Australia

No email / No phone

Status: Recruiting

Princess Margaret Cancer Center

Toronto, Ontario, M4W 3E2, Canada

No email / No phone

Status: Recruiting

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

No email / No phone

Status: Recruiting

START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria

Lisbon, 1649-035, Portugal

No email / No phone

Status: Recruiting

Instituto Portugues De Oncologia Do Porto

Porto, 4200-072, Portugal

No email / No phone

Status: Recruiting

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

No email / No phone

Status: Active, not recruiting

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

No email / No phone

Status: Active, not recruiting

The Catholic University of Korea St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

No email / No phone

Status: Active, not recruiting

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

No email / No phone

Status: Active, not recruiting

Hospital Universitario de Torrejon

Torrejón, 28850, Spain

No email / No phone

Status: Recruiting

Institut Catala d'Oncologia (ICO)-Badalona

Badalona, 08916, Spain

No email / No phone

Status: Recruiting

START Barcelona / HM Nou Delfos

Barcelona, 08023, Spain

No email / No phone

Status: Recruiting

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

No email / No phone

Status: Recruiting

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Central de Asturias (HUCA)

Oviedo, 33011, Spain

No email / No phone

Status: Recruiting

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

No email / No phone

Status: Recruiting

Sharp Memorial Hospital

San Diego, California, 92123, United States

No email / No phone

Status: Recruiting

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

No email / No phone

Status: Active, not recruiting

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

No email / No phone

Status: Recruiting

Emory - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

No email / No phone

Status: Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

No email / No phone

Status: Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Active, not recruiting

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