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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    100
  • sponsor
    Medicenna Therapeutics, Inc.
Updated on 14 July 2022
measurable disease
interleukin 2
mammogram

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.

Description

The study drug, MDNA11, is a selective IL-2 preferentially activating effector T cells (naïve CD8+ T-cells) and NK cells responsible for killing cancer cells, with minimal or no stimulation of the 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 16 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 two parts:

  • Sequential Dose Escalation
  • Dose Expansion in monotherapy as well as with an immune checkpoint inhibitor.

Approximately 100 patients will be enrolled.

Tumor assessment by CT/MRI will be performed every 12 weeks and will continue until documented disease progression. Treatment may continue for up to 1 year, or until treatment discontinuation criteria are met. Patients can withdraw from participation at any time.

Details
Condition Advanced Solid Tumor, Unresectable Solid Tumor, Melanoma, Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer Squamous, Non-Small Cell Lung Cancer Non-squamous, Colorectal Cancer, Gastric Cancer, Biliary Tract Cancer, Gallbladder Cancer, Cervical Cancer, Basal Cell Carcinoma, Bladder Cancer, Merkel Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Cutaneous Squamous Cell Carcinoma, Pleural Mesothelioma, Esophageal Cancer, Hepatocellular Carcinoma, Endometrial Carcinoma, Solid Tumor, Solid Tumor, Adult
Treatment MDNA11 Monotherapy, MDNA11 in combination with checkpoint inhibitor
Clinical Study IdentifierNCT05086692
SponsorMedicenna Therapeutics, Inc.
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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 that is unresectable (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

Exclusion Criteria

Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter. Palliative radiotherapy given within 28 days prior to the first dose of study drug may be approved on a case-by-case basis in discussion with the Sponsor
Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases permitted based on Medical Monitor review
Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers
Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy
Severe pulmonary, cardiac or other systemic disease
Females who are pregnant or lactating or planning to become pregnant during the study
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)
Prior Interleukin therapy
Inability to comply with study and follow up procedures as judged by the Investigator
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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