EpicentRx has dosed the first subject in the Phase III REPLATINUM clinical trial of RRx-001 in third-line and beyond extensive stage small cell lung cancer (SCLC) in China.
The international, multicentre trial is progressing at more than 50 sites in the US and China.
It will assess the efficacy of RRx-001 plus a first-line platinum doublet compared to a platinum doublet in nearly 300 patients who were priorly treated with a platinum doublet and a checkpoint inhibitor.
The licencing partner of the company, SciClone Pharmaceuticals, is overseeing the trial in China.
Progression-free survival (PFS) and overall survival (OS) in study subjects are the primary endpoints of the trial.
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A tumour-activated small molecule, RRx-001 is an investigational NLRP3 inhibitor.
It hinders the NLRP3 inflammasome and repolarises tumour-associated macrophages (TAMs).
The molecule is utilised for restoring sensitivity to chemotherapy.
In 2020, EpicentRx and SciClone entered a licencing agreement for RRx-001 in Greater China.
RRx-001 has so far not been linked to any dose-limiting toxicities either administered alone or along with chemotherapy.
EpicentRx CEO Dr Tony Reid said: “The deck is stacked against patients with SCLC, a highly aggressive and metastatic cancer.
“RRx-001 is a chemosensitizer, with the potential to help SCLC patients around the world by restoring sensitivity to first-line platinum-based chemotherapy.”
The REPLATINUM trial comes after the company successfully concluded the Phase II QUADRUPLE THREAT trial of RRx-001 in patients with late-line SCLC.
QUADRUPLE THREAT met the primary endpoint facilitating the commencement of the REPLATINUM trial.
In February this year, the company began the Phase I PIRATE trial of RRx-001 plus irinotecan and temozolomide to treat recurrent or progressive malignant solid and central nervous system tumours in paediatric patients.