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Compound · clinical trials

Utidelone clinical trials

Also listed in trial records as UTD1
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 12 trials in our China and USA registers that name Utidelone as an intervention. Synced 25 Sep 2026
12Current trials
6Recruiting now
9Lead sponsors
2Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Utidelone is named as an intervention in 12 current clinical trials in our China and USA registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Beijing Biostar Pharmaceuticals Co., Ltd (2). The most-studied condition is Advanced Breast Cancer.

Trials by status

  • Recruiting650%
  • Not yet open650%

Trials by phase

  • Phase 2758%
  • Phase 3325%
  • Phase 2/318%
  • Phase 1/218%
01

Clinical trials of Utidelone

12 trials
StudyPhaseStatusLead sponsorRegisters
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
NCT05430399 · ClinicalTrials.gov ↗ · Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Phase 3 Recruiting Sun Yat-sen University China
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06841679 · Gastric or Gastroesophageal Junction Adenocarcinoma
Phase 2/3 Recruiting Beijing Biostar Pharmaceuticals Co., Ltd. USA, China
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
NCT06102824 · ClinicalTrials.gov ↗ · HER2-negative Breast Cancer, Advanced Breast Cancer
Phase 2 Recruiting Guangdong Provincial People's Hospital China
The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) ๏ผšSingle-arm, Prospective, Open Clinical Study
NCT06125080 · ClinicalTrials.gov ↗ · TNBC - Triple-Negative Breast Cancer
Phase 2 Recruiting Huihua Xiong China
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
NCT06385990 · ClinicalTrials.gov ↗ · Triple Negative Breast Neoplasms
Phase 2 Recruiting Hunan Cancer Hospital China
UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases
NCT05535413 · ClinicalTrials.gov ↗ · Metastatic HER2 Negative Breast Carcinoma, Brain Metastases, Capecitabine
Phase 1/2 Recruiting Hunan Cancer Hospital China
Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer
NCT05172518 · ClinicalTrials.gov ↗ · Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Phase 3 Not yet open Sun Yat-sen University China
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
NCT07684456 · ClinicalTrials.gov ↗ · Advanced Breast Cancer
Phase 3 Not yet open Beijing Biostar Pharmaceuticals Co., Ltd. China
Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer
NCT05983094 · ClinicalTrials.gov ↗ · Breast Cancer, Neoadjuvant Therapy
Phase 2 Not yet open Cancer Institute and Hospital, Chinese Academy of Medical Sciences China
Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)
NCT06510465 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Not yet open RenJi Hospital China
Phase II Study of Utidelone Plus Fruquintinib Combination Therapy for Platinum-Resistant Recurrent Ovarian Cancer
NCT06973421 · ClinicalTrials.gov ↗ · Platinum Resistant Ovarian Cancer
Phase 2 Not yet open Fudan University China
A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer
NCT07363330 · ClinicalTrials.gov ↗ · Cervical Cancer, Recurrent, Metastatic
Phase 2 Not yet open Zhongnan Hospital China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Utidelone

17 conditions
All 17 conditions
Condition (as registered)Trials
Advanced Breast Cancer2
Breast Neoplasms2
Locally Advanced or Metastatic Breast Cancer2
Breast Cancer2
Gastric or Gastroesophageal Junction Adenocarcinoma1
Cervical Cancer1
Recurrent1
Metastatic1
HER2-negative Breast Cancer1
Neoadjuvant Therapy1
TNBC - Triple-Negative Breast Cancer1
Platinum Resistant Ovarian Cancer1
Triple Negative Breast Neoplasms1
Metastatic HER2 Negative Breast Carcinoma1
Brain Metastases1
Capecitabine1
UDT11
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Beijing Biostar Pharmaceuticals Co., Ltd.2
Sun Yat-sen University2
Hunan Cancer Hospital2
Zhongnan Hospital1
Guangdong Provincial People's Hospital1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1
RenJi Hospital1
Huihua Xiong1
Fudan University1
04

By country register

RegisterTrialsRecruiting
Clinical trials in China126
Clinical trials in USA11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Utidelone trials

How many clinical trials are testing Utidelone?

12 current trials in our China and USA registers name Utidelone (also registered as UTD1) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Utidelone trials recruiting patients?

Yes. 6 of the 12 trials are recruiting: 6 with sites in China and 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Utidelone clinical trials?

Beijing Biostar Pharmaceuticals Co., Ltd (2), Sun Yat-sen University (2), Hunan Cancer Hospital (2) and Zhongnan Hospital (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Utidelone works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Utidelone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Utidelone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.