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Advanced Solid TumorPhase 1/2ABILITY-1NCT05086692

A Beta-only IL-2 ImmunoTherapY Study

A Phase 1/2 study testing MDNA11 and Pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor and Unresectable Solid Tumor, run by Medicenna Therapeutics, Inc. at 28 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MDNA11 and Pembrolizumab (KEYTRUDA®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
28 sitesin 8 countries
Study dates
27 Aug 2021to 30 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged at least 18 years (inclusive at the time of informed consent).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
  • Demonstrated adequate organ function
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
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  • Life expectancy of ≥ 12 weeks.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
  • Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

Who cannot join

  • Last administration of prior antitumor therapy:
  • Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.
  • Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (<2 weeks of radiotherapy) to non-CNS disease.
  • Radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment.
  • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.
  • Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.
Show all 18Show fewer
  • Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
  • Condition requiring long-term systemic treatment with either corticosteroids > 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
  • Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
  • Severe pulmonary, cardiac or other systemic disease.
  • Known hepatitis B or C virus infection.
  • Females who are pregnant or lactating or planning to become pregnant during the study.
  • Has had an allogeneic tissue/solid organ transplant.
  • Active infection requiring systemic therapy.
  • Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
  • Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.
  • Known severe hypersensitivity to any component of study drug(s).
  • Inability to comply with study and follow up procedures as judged by the Investigator.

Trial locations and contacts

28 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Nina Merchant contact

604-340-3081

nmerchant@medicenna.com

Melissa Coello contact

267-476-2313

mcoello@medicenna.com

28 sites in 8 countries

Spain8 sites, 6 recruiting

  • Institut Catala d'Oncologia (ICO)-Badalona

    Badalona, 08916

    Recruiting

  • START Barcelona / HM Nou Delfos

    Barcelona, 08023

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Withdrawn

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • START Madrid / Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, 33011

    Withdrawn

  • Hospital Universitario de Torrejon

    Torrejón, 28850

    Recruiting

Other trials in Spain

United States7 sites

  • Emory - Winship Cancer Institute

    Atlanta, Georgia, 30322

    Active, not recruiting

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

    Active, not recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Active, not recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Active, not recruiting

  • Sharp Memorial Hospital

    San Diego, California, 92123

    Active, not recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Active, not recruiting

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

    Active, not recruiting

Other trials in United States

Australia4 sites, 1 recruiting

  • University of the Sunshine Coast

    Buderim, Queensland, 4556

    Active, not recruiting

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120

    Recruiting

  • Scientia Clinical Research

    Randwick, New South Wales, 2031

    Active, not recruiting

  • Macquarie University

    Sydney, New South Wales, 2109

    Active, not recruiting

Other trials in Australia

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

    Active, not recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, Jongno-gu

    Active, not recruiting

  • The Catholic University of Korea St. Vincent Hospital

    Suwon, Gyeonggi-do

    Withdrawn

Other trials in South Korea

Portugal2 sites, 2 recruiting

  • START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria

    Lisbon, 1649-035

    Recruiting

  • Instituto Portugues De Oncologia Do Porto

    Porto, 4200-072

    Recruiting

Other trials in Portugal

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario, M4W 3E2

    Active, not recruiting

Other trials in Canada

Ireland1 site, 1 recruiting

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY

    Recruiting

Other trials in Ireland

Switzerland1 site, 1 recruiting

  • Hautkrebszentrum, Dermatologische Klinik Universitätsspital Zürich

    Zurich, CH-8091

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read the detailed description

The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.

The study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in multiple parts:

  • Monotherapy (MDNA11 alone) dose escalation
  • Monotherapy (MDNA11 alone) dose expansion in select tumor types
  • Combination (MDNA11 + pembrolizumab) dose escalation
  • Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types

Approximately 160 patients will be enrolled.

After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met. Patients can withdraw from participation at any time.

Being tested
MDNA11, Pembrolizumab (KEYTRUDA®)
Keywords
IL-2, IL2, Interleukin-2, cancer, metastatic, ccRCC, TNBC, NSCLC, CRC, GEJ, intrahepatic, extrahepatic, MCC, SCCHN, CSCC, Gastroesophageal Junction, advanced, unresectable, MSI-H, dMMR
Medical subject headings
Carcinoma, Renal Cell, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Basal Cell, Urinary Bladder Neoplasms, Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDNA11Drug

    Also called Interleukin-2 (IL-2)-albumin

    Dose escalation/evaluation - 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).

    Dose expansion - MDNA11 will be administered according to defined mRDE

  • Pembrolizumab (KEYTRUDA®)Drug

    Dose escalation/evaluation - 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).

    Dose expansion - MDNA11+ pembrolizumab will be administered according to defined cRDE

Study groups in NCT05086692
Study groupRoleWhat they receive
MDNA11ExperimentalMDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion
Receives: Drug: MDNA11; Drug: Pembrolizumab (KEYTRUDA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)

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

    Measured: 24 months

  2. Incidence of Treatment Related Adverse Events (TRAEs)

    Rate of TRAEs in patients with advanced solid tumors

    Measured: 24 months

  3. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Rate of TEAEs in patients with advanced solid tumors

    Measured: 24 months

Secondary outcomes (8)

  1. Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)

    Maximum observed serum drug concentration

    Measured: Up to 24 months

  2. Pharmacokinetic characteristics on MDNA11 - Tmax (h)

    Time to maximum observed serum drug concentration

    Measured: Up to 24 months

  3. Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)

    Area under the serum concentration vs time curve from time zero to the last measurable concentration

    Measured: Up to 24 months

  4. Immunogenicity of MDNA11 (anti-drug antibodies)

    Incidence and persistence of anti-drug antibodies to MDNA11

    Measured: Up to 24 months

  5. Pharmacodynamic effects of MDNA11

    Measurement of translational parameters - Flow cytometry analysis of immune cells in blood and serum measurements of cytokine levels

    Measured: Up to 24 months

  6. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)

    Assessed by RECIST v1.1 and iRECIST; CR+PR/Evaluable N

    Measured: Approximately 24 months

  7. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)

    CR+PR+SD/Evaluable N

    Measured: Approximately 24 months

  8. Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)

    Time from signing ICF to disease progression

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start27 Aug 2021
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Sequential dose escalation (MDNA11 monotherapy and MDNA11 + pembrolizumab) followed by dose expansion with MDNA11 monotherapy and combination (MDNA11 + pembrolizumab).
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05086692
Sponsor's protocol ID
MDNA11-01
Other IDs
KEYNOTE-E53, MK3475-E53, 2023-507536-21-00, 2023
Acronym
ABILITY-1
Status last verified
Oct 2026
First submitted
10 Sep 2021
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MDNA11 and Pembrolizumab (KEYTRUDA®) in people with Advanced Solid Tumor and Unresectable Solid Tumor, run by Medicenna Therapeutics, Inc. at 28 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, United States, Australia, South Korea, Portugal and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nina Merchant (604-340-3081, nmerchant@medicenna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05086692.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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A Beta-only IL-2 ImmunoTherapY Study (NCT05086692) | AzTrials