Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT04778839

Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-06

98

Participants Needed

1

Research Sites

277 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

H

Hangzhou Dihua Biotechnology Co., LTD.

Collaborating Sponsor

AI-Summary

What this Trial Is About

A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.

CONDITIONS

Official Title

Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of advanced solid tumors by histological or cytological examination, with no effective standard anticancer therapy available or failure of standard therapy.
  • Male or female patients aged 18 to 70 years.
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • At least one measurable tumor lesion or assessable non-measurable lesion based on RECIST 1.1.
  • No radiotherapy, chemotherapy, immunotherapy, other anti-tumor therapy, or surgery (except diagnostic biopsy) within 4 weeks prior to enrollment; no planned surgery during study.
  • No severe hematopoietic abnormalities (hemoglobin ≥ 90 g/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L) without recent blood transfusions or growth factors.
  • No serious heart, liver, or kidney diseases (LVEF ≥ 50%; ALT or AST ≤ 2.5x ULN or ≤ 5x ULN with hepatic metastases; total bilirubin ≤ 1.5x ULN; creatinine ≤ 1.5x ULN; creatinine clearance ≥ 60 mL/min).
  • Normal coagulation function (PT, APTT, INR ≤ 1.5x ULN).
  • Willingness to use reliable contraception during study and for 3 months after last dose; women of childbearing age must have negative serum HCG within 14 days prior to enrollment and be non-lactating.
  • Signed informed consent and understanding of study procedures and potential side effects.
  • Good compliance and availability for follow-up.
Not Eligible

You will not qualify if you...

  • Toxicity from previous antitumor therapy not recovered to grade 1 or below (except alopecia or other non-safety risks).
  • Allergy or allergic constitution to Paclitaxel or its components (excluding mild seasonal allergies).
  • Bleeding tendency or receiving thrombolytic or anticoagulant therapy.
  • Previous treatment with paclitaxel with determined resistance.
  • Active central nervous system metastases; stable treated brain metastases allowed.
  • Cerebrovascular accident or transient ischemic attack within past 6 months.
  • Active infection requiring anti-infective or antiviral treatment.
  • History of other malignant cancers within 5 years, except cured basal cell carcinoma or cervical carcinoma in situ.
  • Serious concomitant diseases impacting safety or study completion (e.g., gastrointestinal bleeding, intestinal obstruction, interstitial pneumonia).
  • History of neurological or psychiatric disorders including epilepsy and dementia.
  • Use of CYP2C8 or CYP3A4 inducers/inhibitors within 30 days before study drug.
  • Blood transfusion or blood product use within 2 weeks prior to trial.
  • Peripheral neuropathy above grade II.
  • Recent myocardial infarction, severe or unstable angina, significant arrhythmias, or uncontrolled hypertension.
  • HIV infection, active HBV or HCV infection.
  • Alcohol abuse or drug abuse within 2 weeks before screening.
  • Participation in another study within the last month.
  • Pregnant or nursing women.
  • Any other factors judged by investigators to make participation unsafe or unsuitable.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital,ZheJiang Univercity

Hanzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

J

jian liu, master

CONTACT

X

xiaochen zhang, docter

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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