Clinical Trial Details

A Beta-only IL-2 ImmunoTherapY (ABILITY) Study

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Trial Information

Broad Health Condition Advanced Solid Tumor
Unresectable Solid Tumor
Melanoma
Renal Cell Carcinoma
Sarcoma
Triple Negative Breast Cancer
Pancreatic Ductal Adenocarcinoma
Non-Small Cell Lung Cancer Squamous
Non-Small Cell Lung Cancer Non-squamous
Colorectal Cancer
Gastric Cancer
Biliary Tract Cancer
Gallbladder Cancer
Cholangiocarcinoma
Uterine Cancer
Ovarian Cancer
Cervical Cancer
Basal Cell Carcinoma
Bladder Cancer
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma

Specific Health Condition






















Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC,

Phase of TrialPhase 1/Phase 2

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.
Eligibility

Key inclusion criteria

Key Inclusion Criteria:

    1. Aged at least 18 years (inclusive at the time of informed consent).

    2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

    3. 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.

    4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor
       that is unresectable (see tumor types listed under conditions)

    5. Demonstrated adequate organ function

    6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1)
       and documented by CT and/or MRI.

    7. Life expectancy of = 12 weeks.

    8. 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.

    9. Agree to use highly effective contraception methods. WOCBP must agree to use highly
       effective birth control

  Key Exclusion Criteria:

    1. Received anticancer therapy within 28 days prior to the first dose of study drug(s).

    2. Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases
       permitted based on Medical Monitor review.

    3. Active malignancy (other than the disease under treatment in the study) within the
       previous 3 years except for curable cancers

    4. Clinically significant active, known or suspected autoimmune disease, or diseases that
       can be exacerbated with immunotherapy.

    5. Severe pulmonary, cardiac or other systemic disease.

    6. Females who are pregnant or lactating or planning to become pregnant during the study.

    7. Active infection requiring systemic therapy.

    8. Any medical, emotional or psychiatric condition that interfere with the patient's
       ability to adhere to the protocol

    9. 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.

   10. Known severe hypersensitivity to any component of study drug(s).

   11. Prior Interleukin therapy.

   12. Inability to comply with study and follow up procedures as judged by the Investigator.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Medicenna Therapeutics, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT05086692

Trial IDNCT05086692