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NCT05086692 · ClinicalTrials.gov registry record · Phase 1

A Beta-only IL-2 ImmunoTherapY Study

A Phase 1 study of Advanced Solid Tumor and Gastric Cancer, sponsored by Medicenna Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
115
Enrollment target
20
Study locations

NCT05086692: Recruiting Phase 1 study of Advanced Solid Tumor and Gastric Cancer, sponsored by Medicenna Therapeutics.

NCT05086692 is a Phase 1 study of Advanced Solid Tumor and Gastric Cancer that is actively recruiting participants, run by Medicenna Therapeutics. The registered enrollment target is 115 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05086692, a Phase 1 study of Advanced Solid Tumor and Gastric Cancer, is actively recruiting participants, sponsored by Medicenna Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
115 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)

Conditions Studied

Advanced Solid Tumor Gastric Cancer Cervical Cancer Triple Negative Breast Cancer Clear Cell Renal Cell Carcinoma Basal Cell Carcinoma Unresectable Solid Tumor Non-Small Cell Lung Cancer Squamous Non-Small Cell Lung Cancer Non-squamous Colorectal Cancer (MSI-H)

Interventions

  • DRUG MDNA11
  • DRUG Pembrolizumab (KEYTRUDA®)

Study Locations (20)

Other

  • Mater Misericordiae University Hospital - Dublin
  • START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria - Lisbon
  • Instituto Portugues De Oncologia Do Porto - Porto
  • Institut Catala d'Oncologia (ICO)-Badalona - Badalona

California

  • Sharp Memorial Hospital - San Diego
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
  • Providence Saint John's Health Center - Santa Monica

New South Wales

  • Scientia Clinical Research - Randwick
  • Macquarie University - Sydney

Queensland

  • University of the Sunshine Coast - Buderim
  • Gallipoli Medical Research Foundation - Greenslopes

Gyeonggi-do

  • Seoul National University Bundang Hospital - Seongnam-si
  • The Catholic University of Korea St. Vincent Hospital - Suwon

Florida

  • Boca Raton Regional Hospital - Boca Raton

Georgia

  • Emory - Winship Cancer Institute - Atlanta

Michigan

  • Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2021-08-27
Est. Completion 2026-12-30
Phase Phase 1
Medicenna Therapeutics

2 total trials

What NCT05086692 shows while recruiting

NCT05086692 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (40% lower).

The record links to 10 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which MDNA11 is the first listed.

NCT05086692 names 20 study sites across 12 states, led by Other, California, New South Wales.

Frequently Asked Questions

What is clinical trial NCT05086692 about?

NCT05086692 is a clinical study titled "A Beta-only IL-2 ImmunoTherapY Study". 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.

What is the current status of trial NCT05086692?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2021-08-27. Estimated completion is 2026-12-30.

What conditions does trial NCT05086692 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Gastric Cancer, Cervical Cancer, Triple Negative Breast Cancer, Clear Cell Renal Cell Carcinoma.

What interventions are being tested in trial NCT05086692?

The interventions under investigation include: MDNA11 (DRUG), Pembrolizumab (KEYTRUDA®) (DRUG).

Who is sponsoring clinical trial NCT05086692?

This trial is sponsored by Medicenna Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05086692 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05086692's enrollment target sits among peer trials

115 107th of 189 higher than 83 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05086692

Source: ClinicalTrials.gov NCT05086692, the US trial registry maintained by the National Library of Medicine. NCT05086692 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.