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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    80
  • sponsor
    Medicenna Therapeutics, Inc.
Updated on 28 November 2021
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 (nave 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 approximately 12 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 80 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 Cutaneous Squamous Cell Carcinoma, Malignant Adenoma, Neuroendocrine Carcinoma, cancer of the cervix, bladder cancer, Renal Cell Cancer, Renal Cancer, Advanced Solid Tumor, Uterine Serous Carcinoma, Solid Tumors, Squamous Cell Carcinoma, Renal Cell Carcinoma, Head and Neck Cancer, Neuroendocrine carcinoma, cancer, ovarian, soft tissue sarcomas, gallbladder cancer, bladder disorder, colorectal neoplasm, Breast Cancer, Disorders of cervix NOS, Disorder of uterus NOS, Advanced Malignant Solid Tumor, urinary tract neoplasm, basal cell carcinomas, Skin Squamous Cell Carcinoma, Stomach Cancer, Unresectable Solid Tumor, Rectal Disorders, Gallbladder Disease, Pancreatic Ductal Adenocarcinoma, Kidney Cancer, Soft Tissue Sarcoma, Basal cell carcinoma, Ovarian Function, cancer, colorectal, Bladder Cancer, Urothelial Cancer, Malignant Melanoma, Skin Cancer, Cervical Cancer, Gastric Carcinoma, carcinoma of the bladder, Rectal disorder, cervical cancer, uterine, Melanoma, Urologic Cancer, Uterine Cancer, All Solid Tumors, Gastropathy, head and neck cancer, Squamous Cell Carcinoma of the Head and Neck, squamous cell skin cancer, Metastatic Melanoma, sarcomas, Non-Small Cell Lung Cancer Non-squamous, colorectal tumor, Cholangiocarcinoma, colorectal cancers, cervical carcinoma, Squamous cell carcinoma, Merkel cell carcinoma, Biliary Tract Cancer, Colon cancer; rectal cancer, biliary cancer, Uterine Disorders, skin cancer, Urothelial Tract Cancer, cancer of the ovary, bladder tumor, tumors, colorectal, Connective and Soft Tissue Neoplasm, Colorectal Cancer, Adenocarcinoma, Malignant neoplasm of kidney, carcinoma of cervix, Bladder Carcinoma, melanoma, Squamous Cell Carcinoma of Head and Neck, cancer ovarian, Colon Cancer Screening, Ovarian disorder, Biliary neoplasm, Sarcoma, ovarian tumors, Gall Bladder Disorders, cervix cancer, gastric cancers, Stomach Discomfort, Sarcoma (Pediatric), carcinoma of the cervix, Gastric Cancer, ovarian carcinomas, clear cell renal cell carcinoma, Non-Small Cell Lung Cancer Squamous, Bladder Disorders, Ovarian Cancer, basal cell carcinoma of skin, Recurrent Ovarian Cancer, Gallbladder Carcinoma, Triple Negative Breast Cancer, Malignant neoplasm of gallbladder, Gall Bladder Cancer, carcinoma of the cervix uteri
Treatment MDNA11 Monotherapy, MDNA11 in combination with checkpoint inhibitor
Clinical Study IdentifierNCT05086692
SponsorMedicenna Therapeutics, Inc.
Last Modified on28 November 2021

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

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