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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Investigational Drug AI Analysis

chevron Show for: MDNA11 (MDNA109FEAA)

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Goal: The trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of MDNA11 both as a monotherapy and in conjunction with pembrolizumab in patients with advanced solid tumors.

Patients: The study focuses on adult patients aged 18 and over with locally advanced or metastatic solid tumors. Participants must have an ECOG performance status of 0 or 1, a minimum life expectancy of 12 weeks, and demonstrable adequate organ function.

Design: This is a non-randomized, open-label, dose-escalation and expansion Phase 1/2 study conducted across multiple clinical sites. The study phases include dose escalation and expansion for both monotherapy and combination therapy arms.

Treatments: The investigational drug MDNA11, a long-acting recombinant interleukin-2 (rIL-2) Superkine, is the focal therapy, engineered to target the IL-2 beta receptor on immune effector cells. This design aims to enhance anti-tumor immunity while reducing undesired Treg activation. Combined with pembrolizumab, preliminary data has shown promising responses, including complete responses in some tumor types.

Outcomes: The trial measures the recommended dose for expansion for both monotherapy and combination, along with incidence rates of dose-limiting toxicities, treatment-related adverse events, and treatment-emergent adverse events. Secondary outcomes focus on pharmacokinetic properties such as Cmax, Tmax, and AUClast, immunogenicity, pharmacodynamic effects, anti-tumor activity (ORR, DCR, PFS), and changes in tumor microenvironment immunology.

Burden on patient: Patients will likely face a moderate burden due to frequent medical visits for pharmacokinetic blood sampling, routine imaging every eight weeks, and regular clinical assessments. Additional travel and time commitment will occur for participating at up to 30 clinical sites. However, the trial procedures resemble standard early-phase trial demands for investigational medications, potentially difficult for patients with limited mobility or those living far from trial locations.

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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

Samsung Medical Center

Seoul, Gangnam-gu, Korea, Republic of

No email / No phone

Status: Active, not recruiting

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of

No email / No phone

Status: Active, not recruiting

The Catholic University of Korea St. Vincent Hospital

Suwon-si, Gyeonggi-do, Korea, Republic of

No email / No phone

Status: Active, not recruiting

Seoul National University Hospital

Seoul, Jongno-gu, Korea, Republic of

No email / No phone

Status: Active, not 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

Hospital Universitario de Torrejon

Torrejon, 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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