Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New hope for Hard-to-Treat cancers? utidelone trial underway

NCT ID NCT04911907

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests the drug utidelone in 126 people with advanced solid tumors (excluding breast, lung, and colorectal cancers) that have not responded to standard treatments. The study aims to see if the drug can shrink tumors and how safe it is. Participants receive utidelone infusions for 5 days every 3 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
utidelone injection
What this could lead to
If successful, this could provide a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to all patients. The drug may not shrink tumors or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

126 people

The number who actually took part.

Started

Jan 2021

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) 3. Age 18 -70 years old 4. ECOG performance status of 0-1 5. Life expectancy≥ 3 months 6. Basically normal results from routine blood test within 1 week prior to enrollment 1. Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L 2. Hemoglobin \>= 9 g/dL 3. Platelets \>= 80 x 10\^9/L 7. Basically normal liver and renal functions within 1 week prior to enrollment 1. total bilirubin =\< 1.5 x ULN with direct bilirubin within normal range 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (ALT and AST =\< 5 x ULN is acceptable if liver metastases are present) 3. Creatinine clearance\>=50 ml/min 8. 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) 9. Patients who give written informed consent with good compliance. Exclusion Criteria: 1. 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: 1. Nitrosourea or mitomycin C is within 6 weeks before the first dosage of the study drug; 2. 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); 3. The traditional Chinese medicine with anti-tumor indication is within 2 weeks before the first use of the research medicine. 2. Received other unlaunched clinical research drugs or treatment within 4 weeks before the first dosage of the research drug. 3. 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. 4. Symptomatic peripheral neuropathy CTCAE 5.0 grade evaluation ≥ grade 2 5. With severe allergies to castor oil, or have had serious adverse reactions with anti-microtubule drugs in the past 6. Patients of pregnancy or breast feeding 7. Patients with AEs caused by any previous treatment (including systemic and local treatment) that have not yet restored to GRADE 1 (excluding hair loss) 8. Patient with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 9. Patients with active infections and currently need systemic anti-infective treatment 10. Patient with immunodeficiency, including a positive HIV antibody test. 11. 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). 12. Patients with history of serious cardiovascular and cerebrovascular diseases. 13. Patients with mental disorders or patients with poor compliance. 14. Patients not fitted for this study determined by the investigators.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Luhe Hospital, Capital Medical University

    Beijing, China

  • Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, China

  • Shanghai East Hospital of Tongji University

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.