STCube is set to accelerate clinical trials for biomarker-based colorectal cancer treatment as part of its next-generation immuno-oncology drug development. The company aims to strengthen its competitiveness in the global immuno-oncology market by applying the newly identified immuno-oncology target BTN1A1, which shows high expression rates across various cancer types, to precision medicine-based treatment strategies.
On the 18th, STCube announced that it has submitted an Investigational New Drug (IND) application for the Phase 1b/2 clinical trial of ‘Nelmastobat’ for the treatment of metastatic colorectal cancer to the Ministry of Food and Drug Safety (MFDS) in South Korea.
The clinical trial will be conducted as a sponsor-initiated trial (SIT), aiming to secure data that meets the approval standards of global regulatory agencies including the U.S. Food and Drug Administration (FDA), thereby maximizing competitiveness in technology licensing negotiations with multinational pharmaceutical companies.
The trial targets patients with metastatic or recurrent colorectal cancer who are refractory or intolerant to oxaliplatin- and irinotecan-based chemotherapy. Nelmastobat will be added to the combination therapy of trifluridine/tipiracil (TAS-102) and bevacizumab, which is considered the most effective standard treatment, to evaluate efficacy and safety. The study will be conducted at five university hospitals in South Korea, including Korea University Anam Hospital.
In Phase 1b (minimum 6 patients), the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the combination therapy of Nelmastobat, TAS-102, and bevacizumab will be determined. The goal is to identify dose-limiting toxicities (DLT) within the first half of this year.
In Phase 2 (minimum 52 patients), the study will evaluate efficacy in patients with BTN1A1-positive metastatic or recurrent colorectal cancer (BTN1A1 tumor proportion score of 50 or higher), using progression-free survival (PFS) as the primary efficacy endpoint.
Through this clinical trial, STCube aims to confirm the therapeutic value of BTN1A1-based immuno-oncology drugs in the colorectal cancer market, which has not been successfully addressed by existing immune checkpoint inhibitors. Given the well-validated scientific rationale for BTN1A1, the company expects to maximize clinical outcomes through biomarker-based clinical trials going forward.
Yoo Seung-han, Chief Scientific Officer (CSO) of STCube, stated, "While investigator-initiated trials opened the possibility of Nelmastobat as a colorectal cancer treatment, this clinical trial is designed to meet the commercial demands of the global market and to conduct in-depth research."
He added, "Currently, PD-L1 expression in colorectal cancer is extremely limited, with less than 5% of patients eligible for treatment with existing immune checkpoint inhibitors," and "patients with a BTN1A1 tumor proportion score (TPS) of 50% or higher account for about 30% of all colorectal cancer patients." Furthermore, he explained, "Nelmastobat, targeting this biomarker, is expected to be a highly effective treatment option for patients resistant to chemotherapy."
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