utidelone IV (UTD1) / Beijing Biostar Technologies, Luye Group - LARVOL DELTA

Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective, single-arm, phase 2 study. (PubMed, BMC Med) - P2 | "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."

Journal • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • HER-2

A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Zhongnan Hospital

New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Study on the efficacy of Utidelone combined with Anotinib in the treatment of advanced Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=61 | Not yet recruiting | Sponsor: Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen Un

New P2 trial • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A single-arm exploratory clinical trial of Utidelone injection for advanced pancreatic cancer refractory to standard therapy (ChiCTR) - P=N/A | N=48 | Recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

New trial • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and safety of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy in breast cancer patients: a systematic review and meta-analysis. (PubMed, Front Neurol) - "Chemotherapeutic agent subgroup analysis showed that acupuncture was beneficial for taxane-induced CIPN (RD = 0.26, 95% CI: 0.14, 0.38; p < 0.001) and utidelone-induced CIPN (RD = 0.33, 95% CI: 0.10, 0.56; p = 0.004), while the effect for CIPN from unspecified agents was not statistically significant (RD = 0.11, 95% CI: -0.20, 0.43; p = 0.484)...These findings support acupuncture as a safe and effective adjunct for CIPN symptom management in breast cancer patients. https://www.crd.york.ac.uk/, identifier [CRD42024615214]."

Journal • Retrospective data • Review • Breast Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "This treatment approach warrants further validation in a randomized clinical trial. ClinicalTrials.gov Identifier: NCT05357417."

Clinical • Journal • P2 data • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Utidelone plus bevacizumab for the treatment of HER2-positive breast cancer brain metastases (U-BOMB-HER): A multicenter, single-arm phase IIstudy (SABCS 2025) - P2 | "Preliminary findings from the U-BOMB-HER study indicate that utidelone plus bevacizumab demonstrates clinically meaningful CNS activity, along with a manageable safety profile, in patients with HER2-positive breast cancer brain metastases, refractory to trastuzumab and TKI. ClinicalTrials.gov: NCT05357417."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Biostar Pharma…announced that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM) (PRNewswire-Asia) - "The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR)."

Trial status • HER2 Negative Breast Cancer

Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=192 | Recruiting | Sponsor: Sun Yat-sen University | Enrolling by invitation ➔ Recruiting

Enrollment status • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Utidelone in refractory advanced or metastatic soft tissue sarcoma (UTISARC): Updated analysis of efficacy and safety (ESMO 2025) - P2 | "Conclusions This study demonstrated promising anti-tumour activity of utidelone in patients with refractory STS. Further exploration of novel combination therapies involving utidelone is warranted to enhance its clinical utility."

Clinical • Metastases • Angiosarcoma • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

The FDA Granted Orphan Drug Designation to Biostar Pharma's Utidelone for the Treatment of Pancreatic Cancer (PRNewswire)

Orphan drug • Pancreatic Cancer

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Biostar Pharma, Inc. | Initiation date: Jan 2025 ➔ Jul 2025

Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study. (PubMed, Ther Adv Med Oncol) - "Utidelone (UTD1), a genetically engineered epothilone derivative, has been approved in China for use in combination with capecitabine in treating metastatic breast cancer (MBC) patients previously treated with anthracyclines or taxanes. Patients with unresolved PN from previous therapy or receiving UTD1 through intravenous infusion on days 1-5 were more likely to develop ⩾grade 3 PN. UTD1 is a new option for patients who have previously received taxanes and anthracyclines, with its clinical toxicity controllable."

Journal • Real-world evidence • Breast Cancer • Oncology • Pain • Solid Tumor

EXPRESS: Utidelone induces mechanical and cold allodynia in mice via TRPA1 activation. (PubMed, Mol Pain) - "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."

Journal • Preclinical • Breast Cancer • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • ATF4 • SOD2 • TRPA1

Utidelone induces apoptosis and autophagy in small cell lung cancer cells through the ROS/AMPK signaling pathway (PubMed, Zhonghua Zhong Liu Za Zhi) - "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."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CCNA2 • CCNB1 • CDKN1A

Adaptive Chemotherapy for the Treatment of Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=192 | Enrolling by invitation | Sponsor: Sun Yat-sen University

New P3 trial • Breast Cancer • Oncology • Solid Tumor

Effects of Electroacupuncture and Mecobalamin for Utidelon-Induced Peripheral Neuropathy in Breast Cancer Patients: A Randomized Controlled Clinical Trial. (PubMed, J Pain Res) - P=N/A | "The chemotherapy agent Utidelone (UTD1), as a novel option for drug-resistant breast cancer patients, is prone to cause severe neurotoxicity...No. ChiCTR2200062741."

Clinical • Journal • Breast Cancer • Oncology • Pain • Solid Tumor

Utidelone suppresses PDAC growth and enhances gemcitabine therapy by inducing immunogenic cell death. (PubMed, iScience) - "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."

IO biomarker • Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD4 • CD8 • PD-L1

Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients (clinicaltrials.gov) - P3 | N=440 | Not yet recruiting | Sponsor: Fudan University

Monotherapy • New P3 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Effcacy and safety results of a multi-center phase I/II study of utidelone capsule, a novel oral microtubule inhibitor. (ASCO 2025) - P1 | "Phase II is for UTD2 at 60mg/m2/d-5day in combination with capecitabine at 1000mg/m2 bid-14day in a 21-day cycle for metastatic BC, with ORR as the primary objective. This study demonstrated UTD2's good bioavailability as a microtubule inhibitor, manageable safety, and promising combination therapy efficacy consistent with the injectable formulation for the treatment of advanced BC. The final data will be provided at the time of presentation."

Clinical • P1/2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor

Efficacy and safety results of a multi-center phase I study of utidelone capsule, a novel oral microtubule inhibitor, in advanced solid tumor patients. (ASCO 2025) - P1 | "This completed study demonstrates encouraging anti-tumor activity with manageable safety of UTD2 in patients with heavily pre-treated advanced solid tumors. The results support continuing development of UTD2 for the upcoming phase II/III studies for gastric and ovarian cancers."

Clinical • Metastases • P1 data • Appendix Cancer • Breast Cancer • Fatigue • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Testicular Cancer

Utidelone in combination with etoposide and bevacizumab in HER2-negative breast cancer patients with brain metastasis: A prospective, single-arm, phase II trial. (ASCO 2025) - P=N/A | "The median CNS-PFS was 15 months (95% CI, 6.760-23.240), with supportive treatment for some of the patients after extracranial progression which included etoposide re-administration, or abraxane, endocrine therapy, radiotherapy and immunotherapy. Utidelone in combination with etoposide and bevacizumab has shown promising anti-tumor activity and manageable toxicity in HER2 negative breast cancer patients with brain metastasis, and a randomized control trial is warrantied."

Clinical • Combination therapy • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • HER-2

Efficacy and safety results of a multi-center phase II study of utidelone injection in combination with PD-1 inhibitor and chemotherapy for the first-line treatment of advanced gastric and esophagus cancers. (ASCO 2025) - P2 | " Eligible patients were recruited into the two cohorts of metastatic and/or unresectable HER2 negative GC or ESCC, receiving utidelone (30mg/m2/day iv on days 1–5 every 21-day) plus sintilimab (200 mg iv Q3W) and oxaliplatin (130 mg/m2/day Q3W for up to 6 cycles), or utidelone (30mg/m2/day iv on days 1–5 every 21-day) plus tislelizumab (200 mg iv Q3W) and capecitabine (2000mg/m2/day po on days 1–14 every 21-day), respectively, until disease progression or unacceptable toxicity. Utidelone plus PD-1 inhibitor and chemotherapy demonstrated promising efficacy and acceptable safety as first-line treatment for advanced GC and ESCC. There are 11 patients still on the study receiving continuous treatment. The final data will be provided at the time of presentation."

Clinical • Combination therapy • Metastases • P2 data • Anemia • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hypotension • Leukopenia • Neutropenia • Oncology • Pain • Squamous Cell Carcinoma • HER-2

The efficacy and safety of utidelone plus tislelizumab and bevacizumab for advanced or metastatic triple-negative breast cancer (UTILIZABLE) (ESMO-BC 2025) - P2 | "This study shows preliminary efficacy and manageable toxicity of utidelone plus tislelizumab and bevacizumab for pretreated mTNBC, particularly demonstrating intracranial activity, representing a potential therapeutic option for this high-risk population. Limited sample size warrants validation in larger cohorts."

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-1 • PD-L1

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients with Brain Metastases (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor