A Beta-only IL-2 ImmunoTherapY Study

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

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, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11
specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by
preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for
killing cancer cells, with minimal or no stimulation of 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 30 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 multiple parts:

- Monotherapy (MDNA11 alone) dose escalation

- Monotherapy (MDNA11 alone) dose expansion in select tumor types

- Combination (MDNA11 + pembrolizumab) dose escalation

- Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types

Approximately 115 patients will be enrolled.

After commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab),
tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune
confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s),
withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted
if criteria are met. Patients can withdraw from participation at any time.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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