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

Status
Active
Cancer Type
Bile Duct Cancer
Bladder Cancer
Cervical Cancer
Colon/Rectal Cancer
Gallbladder Cancer
Melanoma
Ovarian Cancer
Sarcoma
Stomach/ Gastric Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05086692
Protocol IDs
MDNA11-01 (primary)
NCI-2022-02678
Study Sponsor
Medicenna Therapeutics, Inc.

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.

Objectives

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.

Eligibility

  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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.