Breast Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 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

Key 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05086692

Recruitment Status:

Recruiting

Sponsor:

Medicenna Therapeutics, Inc.

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There are 8 Locations for this study

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Providence Saint John's Health Center
Santa Monica California, 90404, United States
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Emory - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Scientia Clinical Research
Randwick New South Wales, 2031, Australia
Gallipoli Medical Research Foundation
Greenslopes Queensland, 4120, Australia
Princess Margaret Cancer Center
Toronto Ontario, M4W 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05086692

Recruitment Status:

Recruiting

Sponsor:


Medicenna Therapeutics, Inc.

How clear is this clinincal trial information?

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