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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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreOther study objectives
Analysis of immune characteristics of the tumor microenvironment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 (KEYTRUDA®)
2017
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,306 Total Patients Enrolled
Medicenna Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
47 Total Patients Enrolled
Nina MerchantStudy DirectorMedicenna Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received my last cancer treatment within the required timeframe.I have brain metastases but they are stable after treatment.I have received an organ or tissue transplant from another person.I am not on long-term steroids or immunosuppressants.I do not have an active autoimmune disease that could worsen with immunotherapy.I do not have severe lung, heart, or other systemic diseases.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I am currently on medication for an infection.My cancer is advanced or has spread and confirmed by lab tests.My organs are functioning well.My cancer can be measured and has been confirmed by a scan.I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.I am 18 years old or older.I am fully active or can carry out light work.I haven't had any cancer other than the one being treated in this study in the last 3 years.My cancer can be measured by scans.You are expected to live for at least 12 weeks.My cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: MDNA11
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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