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Solid TumorPhase 2NCT04911907

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

A Phase 2 study testing utidelone injection in people with Solid Tumor, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung cancer, and colorectal cancer) that have failed standard of treatment or were unable to perform standard treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
utidelone injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
3 sitesChina
Study dates
22 Jan 2021to 31 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy (including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors) that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate.
  • Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  • Age 18 -70 years old
  • ECOG performance status of 0-1
  • Life expectancy≥ 3 months
  • Basically normal results from routine blood test within 1 week prior to enrollment
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  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Hemoglobin >= 9 g/dL
  • Platelets >= 80 x 10^9/L
  • Basically normal liver and renal functions within 1 week prior to enrollment
  • total bilirubin =< 1.5 x ULN with direct bilirubin within normal range
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (ALT and AST =< 5 x ULN is acceptable if liver metastases are present)
  • Creatinine clearance>=50 ml/min
  • Women and men of childbearing potential must agree to take effective contraceptive measures during the study and within six months after the last treatment. Female patients must have negative urinary pregnancy test within 7 days before the first treatment (postmenopausal women must have no menstruation for at least 12 months before they are considered unable to conceive)
  • Patients who give written informed consent with good compliance.

Who cannot join

  • Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to enrollment while participating in this trial, except for the following items:
  • Nitrosourea or mitomycin C is within 6 weeks before the first dosage of the study drug;
  • Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-life periods of the drug (whichever is longer);
  • The traditional Chinese medicine with anti-tumor indication is within 2 weeks before the first use of the research medicine.
  • Received other unlaunched clinical research drugs or treatment within 4 weeks before the first dosage of the research drug.
  • Have undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dosage of study drug, or require elective surgery during the trial period.
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  • Symptomatic peripheral neuropathy CTCAE 5.0 grade evaluation ≥ grade 2
  • With severe allergies to castor oil, or have had serious adverse reactions with anti-microtubule drugs in the past
  • Patients of pregnancy or breast feeding
  • Patients with AEs caused by any previous treatment (including systemic and local treatment) that have not yet restored to GRADE 1 (excluding hair loss)
  • Patient with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Patients with active infections and currently need systemic anti-infective treatment
  • Patient with immunodeficiency, including a positive HIV antibody test.
  • Patients with history of active hepatitis B (hepatitis B virus titer> ULN), allow prophylactic antiviral treatment other than interferon; have a history of hepatitis C virus infection (hepatitis C antibody positive).
  • Patients with history of serious cardiovascular and cerebrovascular diseases.
  • Patients with mental disorders or patients with poor compliance.
  • Patients not fitted for this study determined by the investigators.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Luhe Hospital, Capital Medical University

    Beijing

  • Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing

  • Shanghai East Hospital of Tongji University

    Shanghai

Other trials in China

About this study

Official title: Open, Two-stage, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors After Failure or Intolerability to Standard Treatment

This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung cancer, and colorectal cancer) that have failed standard of treatment or were unable to perform standard treatment.

This trial is divided into 2 stages, screening stage and expansion stage. In the screening stage, 10 patients were enrolled for each tumor type(including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors). Based on the results of the tumor type screening stage, the sponsor and the main investigator will have a discussion and have the alignment of tumor types to enter the expansion stage. The expansion stage will refine the inclusion / exclusion criteria and may adjust the treatment plan based on the tumor type and the combination drug selection. A total of 30-50 patients (including patients enrolled in the screening stage) were enrolled in each specified tumor type during the expansion stage.

Conditions
Solid Tumor
Being tested
utidelone injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • utidelone injectionDrug

    Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Study groups in NCT04911907
Study groupRoleWhat they receive
Squamous cell carcinoma of head and neck: Utidelone InjectionExperimentalCohort 1 Squamous cell carcinoma of head and neck. Participants will be treated with utidelone monotherapy
Receives: Drug: utidelone injection
Esophageal cancer: Utidelone injectionExperimentalCohort 2 Esophageal cancer. Participants will be treated with utidelone monotherapy.
Receives: Drug: utidelone injection
Stomach cancer: Utidelone injectionExperimentalCohort 3 Stomach cancer. Participants will be treated with utidelone monotherapy.
Receives: Drug: utidelone injection
Pancreatic cancer: Utidelone InjectionExperimentalCohort4 Pancreatic cancer. Participants will be treated with Utidelone monotherapy.
Receives: Drug: utidelone injection
Ovarian cancer: Utidelone InjectionExperimentalCohort5 Ovarian cancer. Participants will be treated with Utidelone monotherapy.
Receives: Drug: utidelone injection
Cholangiocarcinoma: UtideloneExperimentalCohort 6 Cholangiocarcinoma. Participants will be treated with Utidelone monotherapy
Receives: Drug: utidelone injection
Other solid tumors: Utidelone InjectionExperimentalCohort 7 Other solid tumors. Participants will be treated with Utidelone monotherapy
Receives: Drug: utidelone injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response to utidelone treatment

    Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR) ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.

    Measured: 12 months from first study treatment

Secondary outcomes (3)

  1. Clinical benefit rate (CBR)

    Measured: 12 months from first study treatment

  2. Progression free survival (PFS)

    PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator

    Measured: 18 months from first study treatment

  3. Safety profile associated with utidelone injection

    Observe and record incidence of Treatment-Emergent Adverse Events and severe adverse effects associated with utidelone injection

    Measured: 18 months from first study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start22 Jan 2021
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911907
Sponsor's protocol ID
BG01-2002
Status last verified
Jan 2023
First submitted
30 May 2021
Last updated
3 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing utidelone injection in people with Solid Tumor, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response to utidelone treatment (time frame: 12 months from first study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04911907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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