utidelone IV (UTD1)

P2, N=120, Recruiting, Biostar Pharma, Inc. | Initiation date: Jan 2025 --> Jul 2025

Utidelone (UTD1), an epothilone analogue recently approved in China for treating metastatic breast cancer, is recommended in conjunction with capecitabine for patients who have not responded to first-line therapies. Administration of the TRPA1 antagonist HC-030031 significantly alleviated mechanical and cold allodynia in the UTD1-induced pain model, as did two antioxidants, Mito-tempo and edaravone. This study proposes new approaches for mitigating pain caused by UTD1.

Furthermore, the proportions of apoptosis-positive cells and p-AMPKα-positive cells in the UTD1 group were significantly higher compared to the control group, while the levels of Ki-67 positivity were significantly reduced. UTD1 inhibits SCLC cell proliferation, induces G2/M phase arrest, and promotes cell apoptosis and autophagy through the activation of the ROS/AMPK signaling pathway.

P2, N=35, Not yet recruiting, Shanghai Changzheng Hospital; Shanghai Changzheng Hospital

P3, N=192, Enrolling by invitation, Sun Yat-sen University

This treatment approach warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT05357417.

Clinically, UTD1 + GEM demonstrated good tolerability, high disease control rates, and favorable immunophenotypic changes. These findings suggest UTD1 triggers ICD, enhancing immune recognition of tumor cells, and highlight its potential as a therapeutic strategy for PDAC.

P3, N=440, Not yet recruiting, Fudan University

P2, N=120, Recruiting, Beijing Biostar Pharmaceuticals Co., Ltd.

This result was superior to the second-line treatment with nab-paclitaxel, which resulted in a PFS of 8 months and best overall response of stable disease with slight shrinkage. The present case indicates that a combination of utidelone with apatinib/anlotinib exhibited antitumor activity in a patient with HR+/HER2- mBC with BMs. Therefore, this combination offers a promising therapeutic option for the clinical treatment of patients with breast cancer and BMs.

P2, N=118, Not yet recruiting, Beijing Biostar Pharmaceuticals Co., Ltd.

The patient had progressed after targeted therapy with oxitinib, ametinib, and vometinib. Although peripheral neurotoxicity occurred during treatment, it improved after symptomatic treatment. The treatment of EGFR mutant stage IV NSCLC with utidelone combined with pabolizumab has good effect and mild adverse reactions.