STCube's 바카라사이트 카지노사이트 1b clinical trial in colorectal cancer demonstrates tumor reduction in all patients, highlighting strong efficacy and tolerability

[by Ji, Yong Jun] STCube, the developer of the first anti-BTN1A1 inhibitor, ‘Nelmastobart,’ announced on November 10 that it had demonstrated superiority over the current global standard of care with the presentation of two clinical trial results for the treatment of refractory metastatic colorectal cancer.

At the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held from November 7 to 9 (local time), STCube presented the first data from its company-sponsored 바카라사이트 카지노사이트 1b/2 clinical trial, as well as interim analysis results from an investigator-initiated 바카라사이트 카지노사이트 1b/2 study, evaluating Nelmastobart in combination therapy for patients with metastatic or recurrent colorectal cancer who had received three or more prior lines of treatment.

The company-sponsored Phase 1b/2 clinical trial involved a combination regimen of Nelmastobart with trifluridine/tipiracil (TAS-102) and bevacizumab. The Phase 1b clinical trial was designed to evaluate dose-limiting toxicity (DLT) and establish the recommended Phase 2 dose (RP2D). Beginning with Phase 2, the study adopted a biomarker-driven design, enrolling patients with BTN1A1-positive tumors (TPS ≥ 50%). STCube completed the Phase 1b trial in August and is currently conducting Phase 2, with the results presented publicly for the first time at this conference.

The 바카라사이트 카지노사이트 1b safety evaluation revealed no dose-limiting toxicities (DLTs). The most frequently observed adverse events were leukopenia and neutropenia, both associated with chemotherapy rather than with Nelmastobart itself. Based on these findings, the recommended RP2D was established as Nelmastobart 800 mg, TAS-102 35 mg/m2, and bevacizumab 5 mg/kg.

Remarkably, the first treatment efficacy assessment, conducted two months after treatment initiation, demonstrated tumor reduction and strong antitumor activity in all patients. Among the six participants in the Phase 1b clinical trial, two achieved a partial response (PR), while four exhibited decreasing stable disease (SD). Additionally, five patients showed a Tumor Proportion Score (TPS) of 50 or higher. According to the company, based on the predefined efficacy criteria (BTN1A1 TPS ≥ 50), the objective response rate (ORR) was 40% (2/5), and the disease control rate (DCR) reached 100% (5/5), indicating that the initial data exceeded the current standard of care.

Subsequently, results from an investigator-initiated clinical trial of Nelmastobart were also disclosed. Professor Lee Soo-hyun and her research team from the Department of Oncology at Korea University Anam Hospital presented findings from the 바카라사이트 카지노사이트 1b and 바카라사이트 카지노사이트 2 trials evaluating the combination therapy of Nelmastobart + capecitabine.

The clinical trial enrolled a total of 52 patients with refractory metastatic colorectal cancer, most of whom belonged to a population known to exhibit poor responsiveness to immunotherapy. Among them, 30 patients (57.7%) had liver metastases, 42 (80.8%) had microsatellite-stable (MSS) colorectal cancer, and 23 (44.2%) carried genetic mutations (RAS or BRAF). In the 바카라사이트 카지노사이트 2b trial, no DLTs associated with nelmastobart were reported, and the RP2D was confirmed as nelmastobart 800 mg and capecitabine 1000 mg/m2.

The efficacy analysis (data cutoff date: June 13, 2025) revealed that 7 out of the 52 enrolled 바카라사이트 카지노사이트 achieved a partial response (PR), while 33 exhibited stable disease (SD), resulting in an objective response rate (ORR) of 13.5% (7/52) and a disease control rate (DCR) of 77.0% (40/52). The median progression-free survival (mPFS) was 4.2 months, indicating superior therapeutic efficacy compared with the standard of care (ORR 0-6%, mPFS 2-3 months). As several 바카라사이트 카지노사이트 remain on treatment, the final analysis, including overall survival (OS), has been rescheduled for release in H1 2026.

The combination therapy was generally well tolerated, with the most common adverse events being hand-foot syndrome and stomatitis. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 5.8% of 바카라사이트 카지노사이트. However, none were associated with Nelmastobart. Adverse reactions attributed to Nelmastobart were mild (Grade 1) and included flu-like symptoms accompanied by drowsiness and myalgia. No treatment-related deaths were reported.

"An ORR of 13.5% and a median PFS of 4.2 months in patients with metastatic colorectal cancer who had failed standard therapies after third-line treatment or later represent highly encouraging clinical outcomes, surpassing the ORR of 0-6% and median PFS of 2-3 months typically observed with existing standard treatments," said Professor Lee Soo-hyun of the Department of Oncology at Korea University Anam Hospital. "In terms of safety, no significant adverse events were observed other than toxicities associated with capecitabine, underscoring the excellent safety profile for Nelmastobart as a combination therapy," she added.

"After securing additional follow-up data, including survival outcomes and biomarker (BTN1A1) analyses, we plan to release the final results around mid-2026. We anticipate that the Nelmastobart combination therapy will emerge as a promising treatment option for patients with metastatic colorectal cancer who currently face limited treatment alternatives," Lee further commented.

“The combination therapy of Zanzalintinib, a multi-targeted tyrosine kinase inhibitor (TKI) developed by Exelixis, and atezolizumab, an anti-PD-L1 immune checkpoint inhibitor, was recently published in The Lancet, demonstrating an improvement in mOS of 10.9 months compared to the standard treatment, regorafenib (9.4 months), in the Phase 3 clinical trial (STELLAR-303) for patients with MSS colorectal cancer refractory to existing therapies. However, the ORR was only 4%, and the mPFS was only 3.7 months. Moreover, the TRAEs of grade 3 or higher reached 60%, exceeding that of regorafenib (37%). In comparison, the Nelmastobart combination therapy demonstrated markedly superior outcomes in ORR, mPFS, and safety,” explained Stephen Sung-han Yoo, Chief Scientific Officer (CSO) of STCube.

"These findings clearly highlight the clinical value of BTN1A1-targeted immunotherapy, demonstrating antitumor efficacy that surpasses global standards. Five months after dosing the first patient in the company-sponsored clinical trial, all participants in the Phase 1b study continue to exhibit sustained therapeutic responses. The Phase 2 trial is also yielding excellent ongoing results, further raising expectations for forthcoming data," Yoo further emphasized.

Conversely, STCube is accelerating its 바카라사이트 카지노사이트 2 clinical trial targeting patients with a BTN1A1 TPS of 50% or higher. The company-sponsored 바카라사이트 카지노사이트 2 trial for metastatic and recurrent colorectal cancer has thus far enrolled and initiated treatment in 26 patients, with full enrollment expected by the end of the year. In addition, a 바카라사이트 카지노사이트 2 clinical trial evaluating the Nelmastobart + docetaxel combination therapy in patients with advanced and metastatic non-small cell lung cancer (NSCLC) who have progressed beyond second-line therapy is scheduled to begin patient enrollment within the year.