NCT05086692

A Beta-only IL-2 ImmunoTherapY Study

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Medicenna Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor
• Unresectable Solid Tumor
• Clear Cell Renal Cell Carcinoma
• Triple Negative Breast Cancer
• Non-Small Cell Lung Cancer Squamous
• Non-Small Cell Lung Cancer Non-squamous
• Colorectal Cancer (MSI-H)
• Gastric 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
• Endometrial Carcinoma
• Solid Tumor
• Solid Tumor, Adult
• MSI-H Solid Malignant Tumor
• Cancer With A High Tumor Mutational Burden
• Epithelial Ovarian Carcinoma
• Primary Peritoneal Cancer
• Gastroesophageal Junction (GEJ) Cancer
• Acral Melanoma
• Mucosal Melanoma
• Cutaneous Melanoma
• DMMR Solid Malignant Tumor
• Fallopian Tube Cancer
• Ovarian Cancer
• MSI-H Cancer
• DMMR Cancer
• Pancreas Adenocarcinoma (MSI-H)
• Skin Cancer
• Viral Cancer
• Cervical Cancers
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	MDNA11	MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).
DRUG	Pembrolizumab (KEYTRUDA®)	MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).

Timeline

• Start date: 2021-08-27
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2021-10-21
• Last updated: 2025-07-09

Locations

27 sites across 7 countries: United States, Australia, Canada, Ireland, Portugal, South Korea, Spain

Regulatory

• FDA-regulated drug study