utidelone IV (UTD1)

P=N/A, N=48, Recruiting, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

P2, N=61, Not yet recruiting, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen Un

The combination of inetetamab, camrelizumab, and utidelone demonstrated promising efficacy and a manageable safety profile in heavily pretreated patients with HER2-positive MBC. These findings support this regimen as a viable treatment option in this setting and warrant further investigation in randomized controlled trials.

P2, N=32, Not yet recruiting, Zhongnan Hospital

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

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.