RecruitingPhase 1Phase 2NCT05086692

A Beta-only IL-2 ImmunoTherapY Study

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

Sponsor

Medicenna Therapeutics, Inc.

Enrollment

115 participants

Start Date

Aug 27, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Unresectable Solid Tumor Clear Cell Renal Cell Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer immunotherapy drug that works by activating the immune system's T cells in a more targeted way — designed to be more effective with fewer side effects than standard IL-2 therapies. It is open to people with various types of advanced solid tumors (cancers in organs or tissues rather than blood). **You may be eligible if...** - You have been diagnosed with an advanced or metastatic solid tumor (such as kidney, lung, breast, or other cancers) that has been confirmed by biopsy - Your cancer can be measured on imaging scans - You are in reasonably good physical health - You are 18 or older with a life expectancy of at least 12 weeks - Your organ function (blood counts, kidneys, liver) is adequate **You may NOT be eligible if...** - You received cancer treatment within 4 weeks before starting (or 2 weeks for radiation) - You have active autoimmune disease or are taking immune-suppressing medications - You have active brain metastases (cancer spread to the brain) - You are pregnant or breastfeeding - You have had a prior severe reaction to immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMDNA11

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).

DRUGPembrolizumab (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05086692

Related Trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies

NCT0721383011 locations

Study in Advanced Solid Tumor Patients

NCT0730094311 locations

A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

NCT0683300813 locations

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

NCT0553614125 locations

HEC169096 in Participants With Advanced Solid Tumors

NCT054516021 location