A Beta-only IL-2 ImmunoTherapY Study
Bile Duct Cancer
Bladder Cancer
Cervical Cancer
Colon/Rectal Cancer
Gallbladder Cancer
Melanoma
Ovarian Cancer
Sarcoma
Stomach/ Gastric Cancer
18 Years and older, Male and Female
MDNA11-01 (primary)
NCI-2022-02678
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.
Eligibility
- 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 (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.
Treatment Sites in Georgia
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