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

INTRODUCTION

  • Org Study ID: MDNA11-01
  • Secondary ID: N/A
  • NTC ID: NCT05086692
  • Sponsor: Medicenna Therapeutics, Inc.

BRIEF 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, 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.

  • Overall Status
    Recruiting
  • Start Date
    August 27, 2021
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D) for MDNA11

Primary Outcome 1 - Timeframe: 12 months

Primary Outcome 2 - Measure: Incidence of Treatment Related Adverse Events (TRAEs)

Primary Outcome 2 - Timeframe: 12 months

Primary Outcome 3 - Measure: Incidence of Treatment Emergent Adverse Events (TEAEs)

Primary Outcome 3 - Timeframe: 12 months

CONDITION

  • Advanced Solid Tumor
  • Unresectable Solid Tumor
  • Melanoma
  • Renal Cell Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Triple Negative Breast Cancer
  • Cutaneous Melanoma
  • Non-Small Cell Lung Cancer Squamous
  • Non-Small Cell Lung Cancer Non-squamous
  • Colorectal Cancer
  • Gastric Cancer
  • Biliary Tract Cancer
  • Gallbladder 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
  • Hepatocellular Carcinoma
  • Endometrial Carcinoma
  • Solid Tumor
  • Solid Tumor
  • Adult

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nina Merchant, Martin Bexon, MBBS

Role: Study Director, Study Chair

Affiliation: Medicenna Therapeutics, Medicenna Therapeutics

Overall Contact

Name: Nina Merchant, Martin Bexon, MBBS

Phone: 604-340-3081, 267-476-2313

Email: nmerchant@medicenna.com, mcoello@medicenna.com

LOCATION

Facility Status Contact
Facility: Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Status: Recruiting Contact: N/A
Facility: Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Status: Recruiting Contact: N/A
Facility: Emory - Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Status: Recruiting Contact: N/A
Facility: Scientia Clinical Research
Randwick, New South Wales 2031
Australia
Status: Recruiting Contact: N/A
Facility: Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
Australia
Status: Recruiting Contact: N/A
Facility: ICON Cancer Center
South Brisbane, Queensland 4101
Australia
Status: Recruiting Contact: N/A
Facility: Princess Margaret Cancer Center
Toronto, Ontario M4W 3E2
Canada
Status: Recruiting Contact: N/A