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Advanced Solid TumorPhase 1NCT06632574

A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors

A Phase 1 study testing paclitaxel cationic liposomes in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
paclitaxel cationic liposomes
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
19 Mar 2014to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age ≥ 18 years.
  • 2. Histologically or cytologically diagnosed advanced solid tumors suitable for arterial infusion chemotherapy, including but not limited to the following types:
  • Gastrointestinal tumors (e.g., gastric cancer, liver cancer, cholangiocarcinoma, pancreatic cancer, colorectal cancer, etc.);
  • Gynecological tumors (e.g., ovarian cancer, endometrial cancer, etc.);
  • Non-small cell lung cancer (NSCLC);
  • Liver metastases.
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  • 3. According to RECIST 1.1, at least one measurable lesion in the arterial infusion area.
  • 4. If life-threatening primary lesions are within the arterial infusion area, limited lesions outside the arterial infusion area at baseline are acceptable.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • 6. Life expectancy of at least 3 months.
  • 7. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^2/L.
  • Platelets (PLT) ≥ 100 × 10^9/L.
  • Hemoglobin (Hb) ≥ 90 g/L.
  • Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for individuals with liver metastasis or liver cancer, TBIL ≤ 2 × ULN.
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × ULN; for liver metastasis or liver cancer, ALT, AST ≤ 5 × ULN.
  • Creatinine clearance (Ccr) > 50 mL/min (calculated using the Cockcroft-Gault formula).
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; international normalized ratio (INR) ≤ 1.5 × ULN.
  • 8. Fertile individuals (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 6 months after the last dose of study medication. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
  • 9. Fully understand the clinical trial and voluntarily sign a written informed consent form.

Who cannot join

  • 1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or participated in another clinical trial within 4 weeks prior to the first administration of the study drug, or within 4 weeks or 5 half-lives of the treatment drug (whichever is shorter).
  • 2. Known symptomatic central nervous system or meningeal metastases, or other evidence of uncontrolled central nervous system or meningeal metastases, deemed unsuitable for enrollment by the investigator.
  • 3. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigator).
  • 4. Concurrent participation in another clinical trial, unless it is observational (non-interventional) or in the follow-up period of an interventional trial.
  • 5. Major surgery or invasive intervention within 28 days prior to the first dose.
  • 6. Use of any anti-cancer herbal or traditional Chinese medicine approved by the National Medical Products Administration (NMPA) within 14 days prior to the first dose.
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  • 7. Known severe allergic reactions to the study drug or its components/excipients.
  • 8. Active bacterial, fungal, or viral infections requiring intravenous antibiotic, antifungal, or antiviral treatment prior to the first dose. Participants receiving prophylactic infection treatment with no signs of active infection may be considered for enrollment.
  • 9. History of immunodeficiency diseases, including positive HIV antibodies.
  • 10. Hepatitis B surface antigen (HBsAg) positive with HBV DNA above the measurable limit or 1000 copies/mL (500 IU/mL) (whichever is lower), or HCV antibody positive with HCV RNA above the measurable limit or 1000 copies/mL (whichever is lower). Individuals whose levels are reduced to below the standard following antiviral treatment may be screened.
  • 11. Underlying medical conditions (including laboratory abnormalities), alcohol or drug abuse, or dependence that may impair the administration of study drugs or interpretation of drug toxicity and adverse events (AEs), or lead to insufficient or reduced trial compliance.
  • 12. Severe cardiovascular disease history, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities requiring clinical intervention, such as ventricular arrhythmias or grade II-III atrioventricular block;
  • Average QTcF > 450 ms from three resting 12-lead ECGs;
  • Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months prior to the first dose;
  • New York Heart Association (NYHA) class II or higher, or left ventricular ejection fraction (LVEF) < 50%;
  • Any factors increasing the risk of QTc prolongation or arrhythmias, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years old, or concurrent use of QT-prolonging drugs.
  • Uncontrolled hypertension (screening systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg).
  • 13.History of other malignancies within the past 3 years or concurrent active malignancies (localized, curable malignancies such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, cervical carcinoma in situ, and in situ breast cancer may be included).
  • 14. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or participants with thromboembolic events within 3 months prior to enrollment.
  • 15. Individuals with coagulopathy or a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.
  • 16. Pregnant or breastfeeding women.
  • 17. Any other reasons deemed by the investigator to make the individual unsuitable for participation in the clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Zhongda Hospital, Southeast University

    Nanjing

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetic Characteristics of Paclitaxel Cationic Liposome for Injection in the Treatment of Patients With Advanced Solid Tumors Via Transcatheter Arterial Infusion Therapy.

This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.

Read the detailed description

This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.

The study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of paclitaxel cationic liposomes for injection administered via transcatheter arterial infusion in the treatment of advanced solid tumors.

Paclitaxel cationic liposomes will be administered via arterial infusion on the first day of each cycle, with each treatment cycle lasting 3 weeks. Eligible participants will receive 4-6 cycles of study treatment. Treatment may be terminated early in the event of the following: disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or any other circumstances meeting the criteria for treatment discontinuation (whichever occurs first).

Being tested
paclitaxel cationic liposomes

What participants receive

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

  • paclitaxel cationic liposomesDrug

    Paclitaxel cationic liposomes is a modified new drug. In this study, administration is performed through arterial catheter infusion.

Study groups in NCT06632574
Study groupRoleWhat they receive
Experimental armExperimentalPatients with advanced solid tumors received arterial infusion chemotherapy with paclitaxel cationic liposomes, at a dosage range of 33 mg/m^2 to 66 mg/m^2.
Receives: Drug: paclitaxel cationic liposomes

What is being measured

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

  1. The incidence of dose-limiting toxicity (DLT)

    Measured: At the end of Cycle 1 ( each cycle is 21 days)

  2. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(according to NCI-CTCAE 5.0)

    Measured: Up to approximately 3 years

Secondary outcomes (13)

  1. AUC0-t

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  2. AUC0-∞

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  3. Cmax

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  4. Kel

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  5. Tmax

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  6. Vd

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  7. t1/2

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  8. CL

    Measured: At the end of Cycle 4 ( each cycle is 21 days)

  9. Overall response rate (ORR)

    Measured: Up to approximately 3 years

  10. Disease control rate (DCR)

    Measured: Up to approximately 3 years

  11. Duration of Response (DoR)

    Measured: Up to approximately 3 years

  12. Progression-Free-Survival (PFS)

    Measured: Up to approximately 3 years

  13. Overall survival (OS)

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted9 Oct 2024
  2. Study start19 Mar 2014
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Mar 2027 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants receive the same treatment, and there is no comparison group.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632574
Sponsor's protocol ID
HA131-003
Status last verified
Oct 2024
First submitted
27 Sep 2024
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing paclitaxel cationic liposomes in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 20 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 ( each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 NCT06632574.

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 9 Oct 2024.

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