Qurient is set to begin a clinical trial combining mocetinostat and Trodelvy. The trial aims to validate the synergy observed in preclinical studies and evaluate the treatment efficacy for triple-negative breast cancer.
On July 29, Qurient announced that it has received approval from the Ministry of Food and Drug Safety for the Investigational New Drug (IND) application for the combination trial of mocetinostat (Q901) and Trodelvy (active ingredient: sacituzumab govitecan).
This clinical trial, led by Yonsei University Severance Hospital, will assess the safety and efficacy of the combination therapy in patients with triple-negative breast cancer (TNBC).
Notably, this trial is significant as it is the first clinical study to combine mocetinostat with a payload antibody-drug conjugate (ADC) targeting topoisomerase I (TOP1), which has shown synergy in preclinical efficacy evaluations.
ADCs are recognized as one of the fastest-growing modalities in the oncology market. Global pharmaceutical companies are pursuing combination therapies as a key strategy to expand the treatment scope of approved ADCs and overcome resistance.
Triple-negative breast cancer is a challenging form of breast cancer that lacks hormone receptors (HR) and human epidermal growth factor receptor 2 (HER2), limiting treatment options. Trodelvy is currently used as a standard therapy for metastatic triple-negative breast cancer, and this trial will evaluate whether the combination with mocetinostat can enhance treatment efficacy and broaden the patient population.
Preclinical mechanistic studies have shown that mocetinostat selectively inhibits CDK7, suppressing the overactivation of the MYC transcription factor, which is frequently observed in triple-negative breast cancer. The drug has demonstrated efficacy across various TNBC models. Additionally, it has shown synergy with TOP1 inhibitors by inhibiting DNA damage repair (DDR) pathway genes, suggesting a dual mechanism to target cancer.
Data presented at the 2026 American Society of Clinical Oncology (ASCO) meeting from the ASCENT-03 and ASCENT-04 trials indicated that Trodelvy improved progression-free survival in patients with DNA homologous recombination repair mutations. The company stated that these results support the combination strategy of mocetinostat and Trodelvy, which induces homologous recombination repair deficiency.
Nam Ki-yeon, CEO of Qurient, expressed optimism, stating, "The combination of CDK7 inhibitors and TOP1 inhibitor-based ADCs has already shown strong evidence in preclinical studies, and we are excited to confirm this in clinical trials. We hope mocetinostat will provide a new treatment option for patients with high unmet needs in triple-negative breast cancer."
Meanwhile, Qurient is a biotech company established in 2008 by the Korea Pasteur Research Institute, with Donggu Bio Pharmaceutical as its largest shareholder.
* This article has been translated by AI.
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