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NCT Number: NCT05086692

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.

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Key information

Conditions

Advanced Solid Tumor Acral Melanoma Adenocarcinoma Adenoma Adnexal Diseases Basal Cell Carcinoma Bladder Cancer Breast Diseases Breast Neoplasms Cancer With A High Tumor Mutational Burden Carcinoma Carcinoma, Basal Cell Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell Carcinoma, Squamous Cell Cervical Cancer Cervical Cancers Clear Cell Renal Cell Carcinoma Colonic Diseases Colorectal Cancer (MSI-H) Colorectal Neoplasms Cutaneous Melanoma Cutaneous Squamous Cell Carcinoma DMMR Cancer DMMR Solid Malignant Tumor DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Carcinoma Endometrial Neoplasms Epithelial Ovarian Carcinoma Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastroesophageal Junction (GEJ) Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms MSI-H Cancer MSI-H Solid Malignant Tumor Male Urogenital Diseases Melanoma Merkel Cell Carcinoma Mesothelioma Mesothelioma, Malignant Mucosal Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Small Cell Lung Cancer Non-squamous Non-Small Cell Lung Cancer Squamous Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreas Adenocarcinoma (MSI-H) Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Mesothelioma Pleural Neoplasms Polyomavirus Infections Primary Peritoneal Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Solid Tumor Solid Tumor, Adult Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Cancer Triple Negative Breast Neoplasms Tumor Virus Infections Turcot syndrome Unresectable Solid Tumor Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Viral Cancer Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scientia Clinical Research, Randwick, New South Wales, Australia

Loading trial locations.

About this study

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 115 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.

Treatment and study plan

MDNA11

Drug

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).

Other names: Interleukin-2 (IL-2)-albumin

Pembrolizumab (KEYTRUDA®)

Drug

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).

Primary outcomes

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

    Time frame: 24 months

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

  2. Incidence of Treatment Related Adverse Events (TRAEs)

    Time frame: 24 months

    Rate of TRAEs in patients with advanced solid tumors

  3. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: 24 months

    Rate of TEAEs in patients with advanced solid tumors

Secondary outcomes

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

    Time frame: Up to 24 months

    Maximum observed serum drug concentration

  2. Pharmacokinetic characteristics on MDNA11 - Tmax (h)

    Time frame: Up to 24 months

    Time to maximum observed serum drug concentration

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

    Time frame: Up to 24 months

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

  4. Immunogenicity of MDNA11 (anti-drug antibodies)

    Time frame: Up to 24 months

    Incidence and persistence of anti-drug antibodies to MDNA11

  5. Pharmacodynamic effects of MDNA11

    Time frame: Up to 24 months

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

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

    Time frame: Approximately 24 months

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

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

    Time frame: Approximately 24 months

    CR+PR+SD/Evaluable N

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

    Time frame: Approximately 24 months

    Time from signing ICF to disease progression

Other outcomes

  1. Analysis of immune characteristics of the tumor microenvironment

    Time frame: Up to 24 months

    Measured by change in Tumor Infiltrating Lymphocyte (TIL) levels

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Coello

CONTACT

[email protected]

267-476-2313

Nina Merchant

CONTACT

[email protected]

604-340-3081

Sponsors and collaborators

Lead sponsor

Medicenna Therapeutics, Inc.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: ABILITY-1

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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