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Interleukin-2 (IL-2) Agonist

MDNA11 + Pembrolizumab for Cancer (ABILITY-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Medicenna Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

ABILITY-1 Trial Summary

This trial is testing a new drug to treat cancer. The drug is given alone or with another drug. The study will see how well the drug works and how safe it is.

Who is the study for?
Adults with advanced solid tumors that can't be surgically removed, who have measurable disease and a life expectancy of at least 12 weeks. They must function relatively well daily (ECOG 0-1), have good organ function, not be pregnant or breastfeeding, and agree to use effective birth control. Exclusions include recent other cancer treatments, active brain metastases, significant autoimmune diseases, certain infections like hepatitis B/C, or any condition that could affect safety or study results.Check my eligibility
What is being tested?
The trial is testing MDNA11 alone or combined with Pembrolizumab in patients with various advanced cancers. It's an early-phase study assessing the drugs' safety profiles, how they move through and affect the body (pharmacokinetics/dynamics), and their preliminary effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to checkpoint inhibition (like inflammation in different organs), infusion-related symptoms from drug administration (such as fever or chills), fatigue from treatment burden on the body's resources, possible digestive disturbances due to systemic effects of therapy.

ABILITY-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Related Adverse Events (TRAEs)
MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)
Secondary outcome measures
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)
Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)
+5 more
Other outcome measures
Analysis of immune characteristics of the tumor microenvironment

ABILITY-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: MDNA11Experimental Treatment2 Interventions
MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,820 Total Patients Enrolled
Medicenna Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
47 Total Patients Enrolled
Nina MerchantStudy DirectorMedicenna Therapeutics

Media Library

MDNA11 (Interleukin-2 (IL-2) Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05086692 — Phase 1 & 2
Oral Squamous Cell Carcinoma Research Study Groups: MDNA11
Oral Squamous Cell Carcinoma Clinical Trial 2023: MDNA11 Highlights & Side Effects. Trial Name: NCT05086692 — Phase 1 & 2
MDNA11 (Interleukin-2 (IL-2) Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086692 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this trial?

"Clinicaltrials.gov indicates that this medical investigation is actively recruiting participants, having initially been uploaded to the portal on August 27th 2021 and last edited on November 1st 2022."

Answered by AI

What is the magnitude of individuals involved in this study?

"This medical trial necessitates the recruitment of 100 eligible individuals. Those wishing to join must meet certain requirements, and can do so at Gabrail Cancer Center Research in Canton, Ohio or Emory - Winship Cancer Institute in Atlanta, Georgia."

Answered by AI

What objectives has this research endeavor set out to fulfill?

"According to the trial sponsor, Medicenna Therapeutics, Inc., one of their primary objectives is to identify MDNA11's Recommended Phase 2 Dose (RP2D) over a period of 12 months. Similarly, they are also assessing secondary metrics such as Time to Maximum Observed Serum Drug Concentration (Tmax), Area Under The Serum Concentration vs Time Curve From Time Zero To Last Measurable Concentration (AUClast), and Pharmacodynamic Effects Of MDNA11 Via Flow Cytometry Analysis Of Immune Cells In Blood And Measurements Of Cytokine Levels."

Answered by AI

Is this the inaugural trial of its kind?

"Currently, 156 active clinical trials for MDNA11 Monotherapy are taking place across 34 nations and 929 cities. The inaugural trial under Key Biologics LLC began in 2006, with 1230 participants completing Phase 2 drug approval. Subsequent to this initial study, a total of 220 further experiments have been completed."

Answered by AI

Could you elucidate on any prior research involving the application of MDNA11 Monotherapy?

"Initially developed in 2006 at The University of Texas MD Anderson Cancer Center, 220 clinical trials have already been completed for MDNA11 Monotherapy. At present, 156 studies are still ongoing with a large portion being conducted out of Canton, Ohio."

Answered by AI

How widespread is the implementation of this trial in our urban area?

"This research study is conducted across 6 sites, including Canton, Atlanta and Boca Raton. To reduce the burden of added travel expenses when enrolling in this trial, patients should choose a medical centre that is closest to them."

Answered by AI

What medical ailments does MDNA11 Monotherapy typically treat?

"MDNA11 Monotherapy is a known remedy for peritonitis and has also been effective in treating liver failure, prevention of hypovolemia, and adult respiratory distress syndrome."

Answered by AI

Who else is applying?

What site did they apply to?
Princess Margaret Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have stage 4 cancer recently diagnosed. I am feeling well, but my doctor is saying they cannot do anything for me other than chemo.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Beta-only IL-2 ImmunoTherapY Study
2021. "A Beta-only IL-2 ImmunoTherapY Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086692.
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