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

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

The Efficacy and Safety of Utidelone Plus Tislelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) (ESMO 2026) - No abstract available

Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Utidelone-associated chemotherapy-induced peripheral neuropathy: an evidence-stratified narrative review of mechanisms, risk identification, and management strategies. (PubMed, Front Oncol) - "In the pivotal phase III BG01-1323L trial, utidelone plus capecitabine improved progression-free and overall survival versus capecitabine alone; however, peripheral neuropathy occurred in 59% of combination patients, including grade 3 in 22%, versus 8% and less than 1%, respectively, with capecitabine alone...Duloxetine has the strongest evidence base for treating established painful CIPN but has not been evaluated specifically for utidelone-associated neuropathy...On the basis of available evidence and established CIPN principles, we propose a practical framework integrating pretreatment neurologic and risk assessment, cycle-by-cycle monitoring, symptom-directed supportive care, fall prevention, rehabilitation, and individualized modification of anticancer treatment. Prospective studies are needed to define the onset, cumulative dose-toxicity relationship, persistence, recovery trajectory, and modifiable risk factors of utidelone-associated neuropathy."

Journal • Review • Breast Cancer • Metabolic Disorders • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor • TRPA1

Utidelone vs Docetaxel in Prior Platinum Treatment NSCLC: A Phase III Open-Label Randomized Trial (ESMO 2026) - No abstract available

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase II Study of Fruquintinib Plus Utidelone in Platinum-Resistant Recurrent Ovarian Cancer (FRUTD Trial) (ESMO 2026) - No abstract available

P2 data • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

A single-arm exploratory clinical trial of Utidelone injection for advanced pancreatic cancer refractory to standard therapy (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and Safety of Utidelone Combined with Anlotinib as Second-Line Therapy for Advanced Non-Specific Soft Tissue Sarcoma: A Multicenter, Single-Arm, Phase II Clinical Study (ChiCTR) - P2 | N=63 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Tumor Hospital; Shandong First Medical University Affiliated Tumor Hospital

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Tianjin Medical University Cancer Institute and Hospital | N=56 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ALK • BRAF • EGFR • NTRK • RET • ROS1

Utidelone exhibits favorable responses in refractory patients with advanced breast cancer. (PubMed, Transl Cancer Res) - "Utidelone plus capecitabine has brought therapeutic and survival benefits in the second-line treatment of patients with advanced breast cancer (ABC). Utidelone demonstrates favorable efficacy and safety in patients with refractory ABC, particularly in HR+/HER2- patients. The combination of utidelone with anti-angiogenic therapy shows promising intracranial anti-tumor activity and is expected to be a preferred option for ABC in subsequent lines of treatment."

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

Utidelone in patients with advanced soft tissue sarcoma refractory to anthracycline and antiangiogenic therapy (UTISARC): a single-arm phase II study. (PubMed, BMC Med) - P2 | "In this exploratory trial, utidelone demonstrated preliminary antitumor activity and a manageable safety profile in patients with refractory soft tissue sarcoma. Further exploration of novel combination therapies involving utidelone is warranted to enhance its clinical utility."

Journal • P2 data • Angiosarcoma • Leiomyosarcoma • Liposarcoma • Oncology • Pain • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Final results of a phase II study of utidelone capsule, the first solid oral microtubule stabilizer, in metastatic breast cancer patients. (ASCO 2026) - P1 | "Here we report the final results of a phase II study of UTD2 in combination with capecitabine (CAP) in mBC. This study demonstrated excellent efficacy of UTD2+CAP in mBC pts. The safety profile with significantly decreased PN and low hematological toxicity highlighted another advantage of this regimen. Utidelone capsule is anticipated to dramatically improve medication convenience and enhance patient compliance."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Efficacy and safety results of a prospective phase II study (IPUtrial) of inetetamab and pyrotinib in combination with utidelone for first- or second-line treatment of HER2-positive metastatic breast cancer. (ASCO 2026) - "Patients who have previously used trastuzumab must meet the followings: for first-line treatment, neoadjuvant therapy was effective, and relapse occurred over 1 year after the end of adjuvant therapy; for second-line treatment, progressed in previous adjuvant/neoadjuvant therapy or progressed within 1 year of completion of trastuzumab therapy; disease progression occurred after 6 months of treatment with trastuzumab in advanced setting. The regimen demonstrated clinically meaningful activity of this triplet regimen for the first/second-line treatment of HER2-positive MBC, evidenced by high ORR (82.4%), durable median PFS (13.1 months), with encouraging 35-month OS rate (78.5%). Predominant toxicities (diarrhea, neuropathy) were controllable through supportive measures and dose adjustments. These data support phase III evaluation of this combination strategy."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Utidelone in heavily pretreated metastatic castration-resistant prostate cancer progressing after docetaxel and novel hormonal agents: Results of a completed phase II trial. (ASCO 2026) - P2 | "Utidelone monotherapy exhibits promising antitumor activity and manageable safety profile in heavily pretreated mCRPC patients, including those who have progressed on ARPIs, abiraterone, and docetaxel. The study results support further investigation of this regimen."

Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2

Atrial fibrillation during palliative chemotherapy with utidelone: a case report. (PubMed, Front Oncol) - "Although a definite causal relationship cannot be confirmed, the close temporal association and clinical course suggest that utidelone may have contributed to the arrhythmias. This case highlights the need for careful cardiac monitoring during treatment."

Journal • Atrial Fibrillation • Breast Cancer • Cardiovascular • Endocrine Disorders • Oncology • Solid Tumor

Utidelone combined with radiotherapy followed by denosumab maintenance in a breast cancer patient with clivus metastasis: a long-term remission case report and literature review. (PubMed, Front Oncol) - "This regimen combines local lesion control with high-dose radiotherapy and systemic chemotherapy with a novel epirubicin microtubule stabilizer, utidelone. Denosumab, which is used for maintenance therapy after concurrent chemoradiotherapy, is valuable for both bone protection and tumor microenvironment regulation and ultimately achieves rapid and durable clinical remission. This report provides a reference for the treatment of similar rare metastatic cases and provides important preliminary evidence for follow-up clinical research."

Journal • Breast Cancer • Oncology • Solid Tumor

Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=79 | Recruiting | Sponsor: Henan Cancer Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ May 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P2 | N=126 | Completed | Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Mar 2024 ➔ May 2025

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ALK • BRAF • EGFR • NTRK • RET • ROS1

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

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

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 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