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Advanced Solid TumorPhase 1NCT04088604

Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors

A Phase 1 study testing LY01610 ( Irinotecan hydrochloride liposome injection ), LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection） and Irinotecan Hydrochloride Injection（CAMPTO®） in people with Advanced Solid Tumor, run by Luye Pharma Group Ltd. at 1 site 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 is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of LY01610 monotherapy and combine with 5-Fu in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LY01610 ( Irinotecan hydrochloride liposome injection ), LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection） and Irinotecan Hydrochloride Injection（CAMPTO®）
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
15 Feb 2019to 17 Dec 2021
Phase
Phase 1
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 18 to 70 years (18 years and 70 years are inclusive).
  • Histologically or cytologically confirmed solid tumor for which failed or could not •tolerate standard treatment, or standard effective treatment does not exist.
  • The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria).
  • The predictable survival duration ≥ 3 months.
  • The Eastern Cooperative Oncology Group (ECOG) performance status score < 2 point.
  • Laboratory results during screening:
Show all 11Show fewer
  • Hematology: Absolute neutrophil count ≥ 1.5× 109/L, platelet count≥ 100× 109/L and hemoglobin≥ 90 g/L;
  • Liver function: Total bilirubin（TBIL）≤ 1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN for the subjects without liver metastasis; ALT and AST≤ 5×ULN for the subjects with liver metastasis;
  • Kidney function: Serum creatinine ≤ 1.5 ×ULN or creatinine clearance rate ≥ 50 mL/min(Cockcroft-Gault formula);
  • The subject has voluntarily signed the written informed consent form (ICF) and can comply with the study protocol;
  • The female subjects of childbearing age and male subjects with fertility potential female partner agree to take reliable contraceptive measures (such as abstinence, sterilizing operation, contraceptives, injection of the contraceptive drug •medroxyprogesterone acetate or subdermal implant of contraceptives) during the study period and within 6 months after infusion of the study drugs.

Who cannot join

  • Patients with brain malignant tumor, lymphoma or other malignant blood diseases;
  • The subjects with symptomatic brain metastasis;
  • Other malignant tumors within 5 years prior to screening (except for stage Ib or lower cervical cancer, non-invasive basal cells or squamous cell skin cancer that have been cured);
  • Patients with uncontrollable ascites, pleural effusion;
  • Ongoing or active systemic infection need intravenous antibiotic treatment;
  • Medical history of the following diseases within 6 months before screening: myocardial infarction, unstable angina, history of coronary revascularization, congestive heart failure (New York Heart Association classification ≥ grade II), severe unstable ventricular arrhythmia, serious arrhythmia which needs drug treatment;
  • The patient with hepatitis B surface antigen (HBsAg) positive and the peripheral blood HBV DNA titer ≥1× 103 copies/mL or 200 IU/ml The subject is eligible to be enrolled if HBsAg is positive and peripheral blood hepatitis B virus (HBV) DNA titer <1×103 copies/ml or 200 IU/ml and the investigator considers that the subject is at the stable stage of chronic hepatitis and the risk will not be increased for the subjects;the patient with hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody positive;
  • Patients still with clinically significant electrolyte disorders that were diagnosed by the investigator before drug administration;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: PhaseⅠStudy of Irinotecan Hydrochloride Liposome Injection (LY01610) About the Safety, Tolerability, Pharmacokinetics (PK)and Preliminary Efficacy in Patients With Advanced Solid Tumors

This is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of LY01610 monotherapy and combine with 5-Fu in patients with advanced solid tumors. Additionally, the pharmacokinetics and preliminary efficacy of LY01610 monotherapy and combine with 5-Fu will be investigated in this study.

Read the detailed description

This study will be conducted in two stages: In the first stage, ascending doses of LY01610 will be administered as monotherapy in participants with solid tumors. The starting dose was 30 mg/m2 and the subsequent dose was increased according to the protocol of 60 mg/m2, 90 mg/m2, 120 mg/m2, 150 mg/m2, 180mg/m2. Each subject received only one dose of the drug, and the next dose group study could only be performed if the previous dose group was completed 21 days of observation after the first dose and safe tolerance was confirmed. According to the subjects' tolerance, appropriate doses will be selected and the safety, PK characteristics and initial efficacy of LY01610 were further evaluated in additional 6 - 8 patients. The interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.Another 8 subjects were enrolled and given CAMPTO® (180 mg/m2) once every 2 weeks to perform the pharmacokinetic profiles.

The second stage is a dose escalation study of LY01610 combined with 5-Fu. Based on the results of the first stage, three doses of low, medium and high doses were selected in combination with a fixed dose of 5-Fu to determine the DLT and MTD. Similarly, according to the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics and initial efficacy of LY01610 combined with a fixed dose of 5-Fu were further evaluated in 6 - 8 patients. The drug was administered every 2 weeks.

Being tested
LY01610 ( Irinotecan hydrochloride liposome injection ), LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）, Irinotecan Hydrochloride Injection（CAMPTO®）
Keywords
LY01610, 5-Fu, Safety, Tolerability, Pharmacokinetics

What participants receive

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

  • LY01610 ( Irinotecan hydrochloride liposome injection )Drug

    Part1-Dose Escalation and Part1-Dose Extension : subjects take LY01610;

  • LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）Drug

    Part2-Dose Escalation and Part2-Dose Extension : subjects take LY01610 with 5-Fu;

  • Irinotecan Hydrochloride Injection（CAMPTO®）Drug

    Irinotecan Hydrochloride Injection（CAMPTO®） pharmacokinetics comparative study

Study groups in NCT04088604
Study groupRoleWhat they receive
LY01610-Dose EscalationExperimentalThe starting dose was 30 mg/m2 IV and the subsequent dose was increased according to the protocol of 60 mg/m2, 90 mg/m2, 120 mg/m2, 150 mg/m2, 180mg/m2. The interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.
Receives: Drug: LY01610 ( Irinotecan hydrochloride liposome injection )
LY01610-Dose ExtensionExperimentalAccording to the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics and initial efficacy of LY01610 were further evaluated in 6 - 8 patients. The interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.
Receives: Drug: LY01610 ( Irinotecan hydrochloride liposome injection )
LY01610 with 5-Fu -Dose EscalationExperimentalDose Escalation: Based on the results of the first stage, three doses of low, medium and high doses were selected in combination with a fixed dose of 5-Fu to determine the DLT, MTD, PK characteristics and the preliminary efficacy. 5-Fu, 400mg/m2 will be administered intravenously on days 1, followed by 600 mg/m2 given as a 22-hour continuous infusion on day 1 and 2, every 2 weeks.
Receives: Drug: LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）
LY01610 with 5-Fu -Dose ExtensionExperimentalSimilarly, according to the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics and initial efficacy of LY01610 combined with a fixed dose of 5-Fu were further evaluated in additional 6 - 8 patients. In dose escalation and dose extension stages, both LY01610 and fixed dose 5-Fu will be given once every 2 weeks.
Receives: Drug: LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）
Hydrochloride Injection- pharmacokinetics comparative studyActive comparatorAfter receiving the MTD of LY01610, another 8 subjects were enrolled and given Irinotecan Hydrochloride Injection（captol ®） (180mg/m2) once every 2 weeks. Upon completion of the pharmacokinetics study, the sponsor will continue to provide the study drug treatment free of charge, and the researcher will conduct treatment and examination according to the subject's situation, without collecting any safety and efficacy data of the subject.
Receives: Drug: Irinotecan Hydrochloride Injection（CAMPTO®）

What is being measured

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

  1. Dose limiting toxicity (DLT)

    The DLT of LY01610 monotherapy was obtained through the dose-increasing study of LY01610

    Measured: 21 days for the LY01610 monotherapy (first treatment cycle of every subjects)

  2. Dose limiting toxicity (DLT)

    The DLT of combination of LY01610 and 5-fu was obtained through the dose-increasing study of LY01610 and 5-Fu

    Measured: 14 days for the LY01610 combined 5-Fu (first treatment cycle of every subjects)

  3. Maximum tolerated dose(MTD)

    The MTD of LY01610 monotherapy was obtained through the single-drug dose increase study

    Measured: 21 days for the LY01610 monotherapy (first treatment cycle of every subjects)

  4. Maximum tolerated dose(MTD)

    The MTD of combination of LY01610 and 5-fu was obtained through the combined dose increase study

    Measured: 14 days for the LY01610 combined 5-Fu (first treatment cycle of every subjects)

Secondary outcomes (11)

  1. AUC

    The AUC of LY01610 monotherapy was obtained through the dose escalation and extension study，the AUC of active comparator CAMPTO® was obtained through the study，and the AUC of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  2. t1/2

    The t1/2 of LY01610 monotherapy was obtained through the dose escalation and extension study，the t1/2 of active comparator CAMPTO® was obtained through the study，and the t1/2 of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  3. Cmax

    The Cmax of LY01610 monotherapy was obtained through the dose escalation and extension study，the Cmax of active comparator CAMPTO® was obtained through the study，and the Cmax of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  4. tmax

    The tmax of LY01610 monotherapy was obtained through the dose escalation and extension study，the tmax of active comparator CAMPTO® was obtained through the study，and the tmax of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  5. Vd

    The Vd of LY01610 monotherapy was obtained through the dose escalation and extension study，the Vd of active comparator CAMPTO® was obtained through the study，and the Vd of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  6. CL

    The CL of LY01610 monotherapy was obtained through the dose escalation and extension study，the CL of active comparator CAMPTO® was obtained through the study，and the CL of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  7. MRT

    The MRT of LY01610 monotherapy was obtained through the dose escalation and extension study，the MRT of active comparator CAMPTO® was obtained through the study，and the MRT of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  8. Kel

    The Kel of LY01610 monotherapy was obtained through the dose escalation and extension study，the Kel of active comparator CAMPTO® was obtained through the study，and the Kel of LY01610 combined with 5-fu was obtained through the dose escalation and extension study.

    Measured: 22 days for the LY01610 monotherapy (first treatment cycle of every subjects)，5 days for the active comparator CAMPTO® (first treatment cycle of every subjects)，and 15 days for the LY01610 combined with 5-fu(first treatment cycle of every subjects)

  9. Best Objective Response Rate

    Preliminary efficacy evaluation of LY01610 and LY01610 combined with 5-fu

    Measured: 8 weeks from enrollment

  10. Progression Free Survival

    Preliminary efficacy evaluation of LY01610 and LY01610 combined with 5-fu

    Measured: from the date of enrollment to the date of disease progression or death up to 24 months from randomisation of the subject

  11. Overall Survival

    Preliminary efficacy evaluation of LY01610 and LY01610 combined with 5-fu

    Measured: from the date of enrollment to the date of death up to 24 months from randomisation of the subject

Timeline

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

  1. First posted13 Sep 2019
  2. Study start15 Feb 2019
  3. Primary completion17 Dec 2021
  4. Study completion17 Dec 2021

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
Non-randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088604
Sponsor's protocol ID
LY01610/CT-CHN-101
Status last verified
Apr 2023
First submitted
22 Aug 2019
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Y, Zhang B, Xu J, Wang X, Tang J, Huang J. Phase I study of liposomal irinotecan (LY01610) in patients with advanced esophageal squamous cell carcinoma. Cancer Chemother Pharmacol. 2021 Sep;88(3):403-414. doi: 10.1007/s00280-021-04294-2. Epub 2021 May 24.

    PubMed 34031756

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY01610 ( Irinotecan hydrochloride liposome injection ), LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection） and Irinotecan Hydrochloride Injection（CAMPTO®） in people with Advanced Solid Tumor, run by Luye Pharma Group 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 11 inclusion and 8 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 26 Apr 2023. 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?

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?

Dose limiting toxicity (DLT) (time frame: 21 days for the LY01610 monotherapy (first treatment cycle of every subjects)). The study lists 4 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 NCT04088604, which also lists 1 linked publication.

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 26 Apr 2023.

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