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

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicenna Therapeutics, Inc.
• Treatments: Interleukin-2

Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. Received anticancer therapy within 28 days prior to the first dose of study drug(s).

2. Has carcinomatous meningitis or leptomeningeal disease; stable CNS metastases permitted based on Medical Monitor review.

3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers

4. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.

5. Severe pulmonary, cardiac or other systemic disease.

6. Females who are pregnant or lactating or planning to become pregnant during the study.

7. Active infection requiring systemic therapy.

8. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol

9. 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.

10. Known severe hypersensitivity to any component of study drug(s).

11. Prior Interleukin therapy.

12. Inability to comply with study and follow up procedures as judged by the Investigator.