The global, multicentre, open-label, adaptive trial will enrol a total of 60 to 90 advanced or metastatic breast cancer patients. Credit: Lordn/Shutterstock.

Processa Pharmaceuticals has dosed the first subject in its Phase II clinical trial of Next Generation Capecitabine (NGC-Cap) to treat patients with advanced or metastatic breast cancer.

This global, multi-centre, open-label, adaptive trial will enrol a total of 60 to 90 patients.

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The study will compare two different doses of NGC-Cap to the Food and Drug Administration (FDA)-approved single-agent capecitabine.

The goal is to assess the safety and efficacy of NGC-Cap, determine optimal dosing regimens according to the FDA’s Project Optimus Initiative, and explore the potential for personalised therapy.

Three clinical sites, including those with multiple locations, have received approval to participate, with additional recruitment underway.

Processa plans to activate around 30 sites globally.

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NGC-Cap is a combination of PCS6422, a dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, and low-dose capecitabine, a prodrug of 5-fluorouracil (5-FU).

Capecitabine is commonly used in chemotherapy for solid tumours.

By inhibiting the DPD enzyme, PCS6422 reduces the conversion of 5-FU into harmful byproducts that cause side effects while enhancing its cancer-killing effects.

Process Pharmaceuticals research and development president David Young said: “Dosing the first patient in this Phase II trial is a significant step in the development of NGC-Cap as a more effective and better-tolerated treatment than widely used capecitabine and 5-FU.

“We expect this Phase II trial to build upon NGC-Cap’s positive Phase IBM findings, and we look forward to announcing the results from our interim analysis of this Phase II trial in mid-2025.”

In July, the company received FDA clearance for its investigational new drug (IND) application to commence the Phase II trial of NGC-Cap in patients with advanced or metastatic breast cancer.