Senhwa Biosciences Announces Positive Clinical Data from Phase 1/Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma
Basal Cell Carcinoma CSR Highlights
- CX-4945 Monotherapy: Progression-free survival (PFS) exceeded 21 months in two patients.
- Optimal Treatment Response: Three patients achieved partial response (PR), while ten patients had stable disease (SD).
- Tolerability & Disease Control Rate: Shows potential superiority over current first- and second-line therapies.
- Unmet Medical Need: Enrolled patients with refractory or recurrent disease who had no remaining treatment options.
Excerpt from the Press Release:
TAIPEI and SAN DIEGO, April 2, 2025 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that the completion of Clinical Study Report (CSR) for Phase 1/Dose Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma(BCC), with positive data outcomes. The study included patients who had relapsed after standard therapies and had no other treatment options. Among them, three patients experienced over 30% tumor reduction (PR), and two patients had a progression-free survival (PFS) exceeding 21 months. CX-4945 significantly prolonged survival in advanced cancer patients, marking a major milestone for both the patients and Senhwa.
Compared to current first- and second-line therapies, CX-4945 demonstrated superior tolerability and disease control potential. Therefore, Senhwa will actively pursue licensing possibilities while carefully evaluating CX-4945’s potential as a monotherapy or in combination with the second-line immunotherapy Libtayo. The company aims to explore further indications and potential as a first-line treatment, offering better options for patients.
Clinical Trial Overview
The trial enrolled 25 patients with locally advanced BCC (laBCC, 20 patients) and metastatic BCC (mBCC, 5 patients). The primary objective was to determine the recommended Phase 2 dose (RP2D) and optimal dosing regimen for CX-4945.
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