- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05865925
Safety, Tolerability, Pharmacokinetics (PK), and Primary Clinical Efficacy of LY01616 in Patients With Advanced Solid Tumors
April 24, 2024 updated by: Luye Pharma Group Ltd.
A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Primary Efficacy of LY01616 (Irinotecan Hydrochloride and Floxuridine Liposome Injection) in Patients With Advanced Solid Tumors
This is a multicenter, open, dose escalation, single and multiple administration phase Ⅰ/Ⅱ clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and primary clinical efficacy of LY01616 in patients with advanced solid tumors
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
78
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Cancer Hospital, Chinese Academy of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. A signed informed consent form (ICF) from the patient or their legally authorized representative. It has fully understood and voluntarily signed the written informed consent for this study, and can comply with the requirements and restrictions listed in the informed consent;
- 2. males or females, ages ≥18 to ≤70 years;
- 3. Patients with advanced solid tumors confirmed by histopathology and/or cytology, who are ineffective or unable to tolerate standard treatment, or who have no standard effective treatment plan (preferred target tumors such as colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, small cell lung cancer, soft tissue sarcoma, cervical cancer, etc.);
- 4. At least one measurable lesion (according to RECIST 1.1 criteria);
- 5.ECOG < 2;
- 6. Organ function meets the following criteria during screening: i.Blood routine examination: neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; ii.Liver function: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5×ULN; If liver metastasis is present, AST and ALT≤5×ULN; iii.Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (Cockcroft-Gault formula).
Exclusion Criteria:
- 1. Having a malignant tumor of the brain or other malignant hematological disease;
- 2. Complicated with symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion and spinal cord compression;
- 3. Other malignancies (except cured cervical cancer of stage IB or lower, and non-invasive basal cell or squamous cell skin cancer) within 5 years prior to screening;
- 4. Uncontrollable large pleural effusion, ascites and pericardial effusion;
- 5. Persistent or active infection requiring intravenous treatment; If there is bleeding as determined by the investigator, it is not appropriate to enroll; Fever (axillary temperature ≥38℃);
- 6. History of acute coronary syndrome, coronary revascularization, New York Heart Association (NYHA) grade ≥II cardiac dysfunction, severe unstable ventricular arrhythmias within 6 months; Or an arrhythmia requiring treatment at the time of screening;
- 7. Anti-hepatitis C virus antibody (HCV-AB) positive, anti-human immunodeficiency virus antibody (anti-HIV) positive or syphilis antibody positive, active hepatitis B [hepatitis B surface antigen (HBsAg) positive test, And peripheral blood HBV DNA titer detection ≥ 1 x 103 copies /mL or 200 IU/ mL; if HBsAg positive, and peripheral blood HBV DNA titer detection < 1 x 103 copies /mL or 200 IU/ mL, If the investigator believes that the subject's chronic hepatitis B is stable and does not increase the subject's risk, the subject will be eligible for admission];
- 8. Electrolyte disturbances with clinical significance judged by the researcher still existed before study administration;
- 9. Severe gastrointestinal disorders (such as gastrointestinal bleeding, infection, chronic enteritis, obstruction, or CTCAE grade 1 or above diarrhea) at the time of screening;lts for drug.
- 10.A past or ongoing history of neuropathy or mental disorder (including epilepsy or dementia);
- 11.Patients with other major organ diseases (such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, rheumatic immune system or metabolic and endocrine system diseases) who are not suitable for inclusion;
- 12.Homozygous mutation of UGT1A1*28 allele (UGT1A1 TA 7/7 genotype)- Only for the dose escalation phase;
- 13.Previous irinotecan treatment;
- 14.Received systemic antitumor therapy (including radiotherapy, chemotherapy or other treatment) within 4 weeks prior to the first administration of study drug;
- 15.CYP3A4 strong inducers (phenytoin or carbamazepine, barbiturates, ripfampicin, or ripapentine, hypericum perforatum, etc.) have been used in the concomitant medication or within 14 days prior to treatment with the experimental drug;
- 16.CYP3A4 strong inhibitors (clarithromycin, ketoconazole or itraconazole, indenavir, lopinavir, nafazoldone, nerfinavir, ritonavir, saquinavir, terapivir, voriconazole, etc.) have been used in the concomitant medication or within 14 days before treatment with the experimental drug;
- 17.The use of UGT1A1 strong inhibitors (azanavir, gefirozil, indinavir, etc.) within 14 days prior to the treatment with the experimental drug.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY010616(30 mg/m2)
30 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
Experimental: LY010616(60 mg/m2)
60 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
Experimental: LY010616(90 mg/m2)
90 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
Experimental: LY010616(120 mg/m2)
120 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
Experimental: LY010616(150 mg/m2)
150 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
Experimental: LY010616(180 mg/m2)
180 mg/m2 measured by Irinotecan hydrochloride, IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter)
|
IV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events (AEs) .
Time Frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
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From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR)
Time Frame: up to 2 years
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up to 2 years
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Disease control rate (DCR)
Time Frame: up to 2 years
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up to 2 years
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Progression-free survival (PFS)
Time Frame: up to 2 years
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up to 2 years
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Area under the curve (AUC) of LY01616
Time Frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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Maximum Concentration (Cmax) of LY01616
Time Frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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Time of maximum concentration (Tmax) of LY01616
Time Frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
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Overall survival (OS);
Time Frame: up to 2 years
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up to 2 years
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Duration of remission (DoR)
Time Frame: up to 2 years
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up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2021
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
April 25, 2023
First Submitted That Met QC Criteria
May 9, 2023
First Posted (Actual)
May 19, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LY01616/CT-CHN-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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