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

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 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

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 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 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

Utidelone combined with anti‑angiogenic therapy for the treatment of anthracycline/taxane‑treated and endocrine‑resistant HR+/HER2‑ refractory breast cancer with brain metastases: A case report. (PubMed, Oncol Lett) - "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."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Real world analysis of the efficacy and safety of eribulin compared to utidelone in combination with capecitabine for the treatment of metastatic breast cancer. (PubMed, Cancer Cell Int) - "In conclusion, either utidelone/capecitabine or eribulin chemotherapy may result in a survival benefit with a tolerable adverse effect profile and favorable safety profile in patients with metastatic breast cancer. The first-line use of eribulin resulted in better PFS and ORR than posterior-line use, and the combination of utidelone/capecitabine represents a more efficacious approach in the advanced first-line therapy of breast cancer."

Journal • Metastases • Real-world • Real-world evidence • Breast Cancer • Dermatology • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor

Efficacy and safety of utidelone plus bevacizumab in the treatment of patients with Her2- metastatic breast cancer study (SABCS 2024) - "This study showed promising efficacy and a manageable safety profile of utidelone plus bevacizumab in the treatment of Her2- MBC patients relapsed after taxanes therapy. This combination regimen could become a new choice for these patients, especially for asymptomatic brain metastasis patients. Further study is warranted with expanded number of patients."

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

Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases (clinicaltrials.gov) - P2 | N=118 | Not yet recruiting | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

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

Utidelone plus pembrolizumab as the fourth-line combination treatment in non-small cell lung cancer with EGFR mutation: a case report. (PubMed, Anticancer Drugs) - "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."

Journal • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PGR

Utidelone-based therapy in advanced or metastatic solid tumors after failure of standard therapies: a prospective, multicenter, single-arm trial. (PubMed, Am J Cancer Res) - "This study demonstrated a promising anti-tumor activity of UTD1 in patients with advanced or metastatic solid tumors after failure of the standard therapies. Moreover, 120 h continuous intravenous infusion was a more tolerable administration mode than 5 days intermittent infusion, and worthy of further study."

Journal • Metastases • Breast Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gynecologic Cancers • Lung Cancer • Oncology • Pain • Solid Tumor