Brief Title: A Beta-only IL-2 ImmunoTherapY (ABILITY) Study

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