Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05086692
PHASE1/PHASE2

A Beta-only IL-2 ImmunoTherapY Study

Sponsor: Medicenna Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2021-08-27

Completion Date

2026-12-30

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

MDNA11

MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).

DRUG

Pembrolizumab (KEYTRUDA®)

MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).

Locations (27)

Sharp Memorial Hospital

San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Emory - Winship Cancer Institute

Atlanta, Georgia, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

MD Anderson Cancer Center

Houston, Texas, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Macquarie University

Sydney, New South Wales, Australia

University of the Sunshine Coast

Buderim, Queensland, Australia

Gallipoli Medical Research Foundation

Greenslopes, Queensland, Australia

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Mater Misericordiae University Hospital

Dublin, Ireland

START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria

Lisbon, Portugal

Instituto Portugues De Oncologia Do Porto

Porto, Portugal

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Institut Catala d'Oncologia (ICO)-Badalona

Badalona, Spain

START Barcelona / HM Nou Delfos

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Hm Sanchinarro

Madrid, Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Hospital Universitario de Torrejon

Torrejón, Spain