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

Bookmark
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
Copy trial ID
More trial details at ClinicalTrials.gov More info

chevron Show Summary from Sponsor

Investigational Drug AI Analysis

chevron Show for: MDNA11 (MDNA109FEAA)

TrialFetch AI Analysis

Goal: Determine tolerable doses of MDNA11 alone and with pembrolizumab for expansion, characterize safety and pharmacology, and assess preliminary antitumor activity in advanced solid tumors.

Patients: Adults with locally advanced or metastatic solid tumors, measurable disease, ECOG performance status 0–1, adequate organ function, and life expectancy of at least 12 weeks. Key exclusions include active CNS metastases, clinically significant autoimmune disease, systemic immunosuppression, active infection, and serious organ disease.

Design: Multicenter, open-label phase 1/2 study with separate monotherapy and combination dose-escalation and tumor-specific expansion parts. There is no randomized comparator. Treatment may continue beyond initial progression if protocol criteria are met.

Treatments: MDNA11 is an investigational, long-acting, albumin-fused IL-2 agonist engineered to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation. In preliminary, nonrandomized conference data, 5 of 20 evaluable checkpoint-inhibitor–experienced patients receiving MDNA11 monotherapy at doses of at least 60 µg/kg had a response; these small-cohort findings do not establish efficacy. Pembrolizumab is a standard PD-1–blocking immune checkpoint inhibitor studied here in combination with MDNA11.

Outcomes: Primary measures are dose-limiting toxicities, recommended monotherapy and combination expansion doses, and treatment-related and treatment-emergent adverse events. Secondary measures include MDNA11 pharmacokinetics, anti-drug antibodies, circulating immune-cell and cytokine changes, overall response rate, disease control rate, and progression-free survival. Changes in tumor-infiltrating lymphocytes are also assessed.

Burden on patient: Likely high, particularly during dose escalation: patients receive study treatment and undergo safety monitoring, pharmacokinetic and immune-marker blood sampling, and CT or MRI approximately every eight weeks. Repeated clinic visits and travel may be more demanding than routine care. The provided information does not establish whether research tumor biopsies are required.

Last updated: Sep 2026

Eligibility More information

chevron Show Criteria

Sites (27)

Sort by distance to:
Clear

Macquarie University

Sydney, New South Wales, 2109, Australia

No email / No phone

Status: Recruiting

Scientia Clinical Research

Randwick, New South Wales, 2031, 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

Instituto Portugues De Oncologia Do Porto

Porto, 4200-072, Portugal

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

Hospital Universitario Central de Asturias (HUCA)

Oviedo, 33011, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

No email / No phone

Status: Recruiting

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

No email / No phone

Status: Recruiting

Hospital Universitario de Torrejon

Torrejón, 28850, Spain

No email / No phone

Status: Recruiting

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, 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

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, 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

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

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

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

No email / No phone

Status: Active, not recruiting

MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Active, not recruiting

Back to trials list