MDNA11 IL-2 Superkine Trial Includes Pleural Mesothelioma

A Phase 1/2 study is testing MDNA11, an engineered interleukin-2 (IL-2) drug, in people with advanced solid tumors, and pleural mesothelioma is one of the cancer types listed in its eligibility.

The trial (NCT05086692), known as ABILITY-1, is sponsored by Medicenna Therapeutics with Merck Sharp & Dohme as a collaborator. It evaluates MDNA11 given alone and in combination with pembrolizumab (Keytruda). It is currently recruiting and aims to enroll an estimated 115 participants across sites in seven countries.

What the Trial Is Testing

ABILITY-1 is an open-label study that evaluates MDNA11 first by itself and then alongside an immune checkpoint inhibitor. The study record describes its structure as sequential dose escalation, testing MDNA11 as a single agent and MDNA11 plus pembrolizumab, followed by a dose-expansion phase using both the monotherapy and the combination.

MDNA11 is described in the trial record as a long-acting “beta-only” recombinant interleukin-2 (IL-2) albumin fusion. According to the record, it is designed to preferentially activate immune effector cells, namely CD8+ T cells and natural killer (NK) cells, while limiting stimulation of regulatory T cells. The fusion to albumin extends its half-life, which the record notes helps avoid frequent dosing.

In the trial, MDNA11 is given intravenously on a once-every-two-weeks schedule. The monotherapy dose-escalation cohorts range from 0.003 to 0.6 mg/kg until the study identifies a recommended dose for expansion. The combination arm pairs MDNA11 with pembrolizumab, also given intravenously, until a separate combination dose for expansion is determined.

Where Mesothelioma Fits In

ABILITY-1 is what researchers call a basket-style study. Rather than focusing on a single cancer, it enrolls people with a broad range of advanced solid tumors. The conditions listed in the trial record include pleural mesothelioma alongside renal cell carcinoma, triple-negative breast cancer, non-small cell lung cancer, colorectal cancer, gastric cancer, cervical cancer, bladder cancer, esophageal cancer, ovarian cancer, and others.

This means the study is not a mesothelioma-specific trial. It is a wider effort to test how MDNA11 performs across many tumor types, with mesothelioma included among the eligible diagnoses.

Who Can Participate

The trial is open to adults aged 18 and older of any sex. Key eligibility requirements from the study record include:

• A histologically or cytologically confirmed locally advanced or metastatic solid tumor
• Measurable disease as defined by RECIST v1.1
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• A life expectancy of at least 12 weeks

The record also lists exclusion criteria, including recent systemic anti-cancer therapy within four weeks, known active central nervous system metastases, a condition requiring long-term systemic corticosteroids above 10 mg daily, clinically significant active autoimmune disease, active hepatitis B or C infection, and a history of allogeneic tissue or organ transplant.

How the IL-2 Approach Differs

Interleukin-2 is a signaling protein that the immune system uses to expand T cells. High-dose IL-2 has been used in cancer treatment for decades, but it can stimulate regulatory T cells, which dampen the immune response, and it can cause significant side effects.

The trial record frames MDNA11 as a “beta-only” IL-2 designed to steer that signaling toward the cancer-killing effector cells, the CD8+ T cells and NK cells, while reducing the regulatory T cell stimulation that can work against the response. The albumin fusion is intended to keep the drug active longer in the body.

Combining an IL-2 agent with a checkpoint inhibitor such as pembrolizumab reflects a common research strategy: one drug aims to expand the immune cells that fight cancer, and the other aims to release the brakes that tumors use to evade them.

What This Trial Does Not Tell Us Yet

ABILITY-1 is an early-phase study. A Phase 1/2 dose-escalation and expansion trial is designed primarily to identify a safe and tolerable dose and to measure early signals of activity, not to prove that a drug works.

The study record does not report posted results. The primary outcome measures listed are the recommended doses for expansion and the incidence of treatment-related and treatment-emergent adverse events, with a 24-month timeframe. Response-related measures, including overall response rate, disease control rate, and progression-free survival, are listed as secondary outcomes. Because mesothelioma is only one of many tumor types enrolled, the trial is not structured to deliver a definitive answer about MDNA11 in mesothelioma specifically.

According to the study record, the trial started in August 2021, with an estimated primary completion date of June 30, 2026, and an estimated overall completion date of December 30, 2026.

Where the Trial Is Available

The study record lists sites in the United States, Australia, Canada, Ireland, Portugal, South Korea, and Spain. As of the most recent update on the record, recruiting United States sites include locations in San Diego and Santa Monica, California; Boca Raton, Florida; Atlanta, Georgia; and Detroit, Michigan. Site status can change, so anyone interested should confirm current openings directly through the ClinicalTrials.gov listing.