New hope for Hard-to-Treat cancers? utidelone trial underway
NCT ID NCT04911907
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
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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 Hide 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.
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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
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Luhe Hospital, Capital Medical University
Beijing, China
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Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, China
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Shanghai East Hospital of Tongji University
Shanghai, China
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