Domestic researchers have officially begun investigator-initiated clinical trials of STCube's immuno-oncology drug candidate ‘Nelmastobat (hSTC810)’ for combination therapy in colorectal cancer. It is expected to secure high-quality data for the development of colorectal cancer treatments.
On the 6th, STCube announced that the first patient dosing for the colorectal cancer investigator-initiated clinical trial phases 1b/2 of Nelmastobat has started.
This investigator-initiated clinical trial will be conducted on a total of 51 to 63 colorectal cancer patients. The purpose is to evaluate the efficacy and safety of combination therapy with Capecitabine and Nelmastobat in metastatic colorectal cancer patients who have failed or are ineligible for oxaliplatin- and irinotecan-based standard chemotherapy. Capecitabine is an oral drug approved for use in solid tumors such as colorectal cancer, gastric cancer, and breast cancer.
In phase 1b, the safety of Capecitabine and Nelmastobat will be confirmed, and the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) will be determined. In phase 2, the efficacy of the combination therapy will be evaluated using the RP2D determined in the phase 1b study.
Colorectal cancer is known as the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related deaths. Metastatic colorectal cancer is usually treated with chemotherapy regimens including oxaliplatin and irinotecan. There are few drugs that have proven effective in the third-line chemotherapy after failure of these two standard treatments, making it a cancer type with high demand for new drug development.
Nelmastobat is an immune checkpoint inhibitor targeting cancer cells expressing the BTN1A1 antigen. According to STCube’s phase 1 clinical data, BTN1A1 is involved in the development of chemoresistance in cancer cells. This suggests that Nelmastobat can effectively eliminate cancer cells with high resistance to chemotherapy, thereby maximizing efficacy when administered in combination with chemotherapy.
An STCube representative said, “We hope that the combination therapy of Capecitabine and Nelmastobat will become a new treatment option for metastatic colorectal cancer patients resistant to existing chemotherapy,” adding, “If meaningful clinical data are secured in this investigator-initiated clinical trial, it will be possible to develop a new innovative drug for metastatic colorectal cancer, which currently has no treatment options.”
They continued, “The first patient dosing for the small cell lung cancer phase 1b/2 trial for commercialization will also begin soon,” and stated, “We are making every effort to secure significant clinical data at this critical time.” They also emphasized, “We will quickly resolve the reasons for being designated as a management stock through performance achievements.”
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