Advanced Solid TumorsPhase 1/2NCT05865925
Safety, Tolerability, Pharmacokinetics (PK), and Primary Clinical Efficacy of LY01616 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing LY010616 in people with Advanced Solid Tumors, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- LY010616
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2021to 30 Oct 2024
- Phase
- Phase 1/2
- 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
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Advanced Solid Tumors
- Being tested
- LY010616
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY010616Drug
Also called Irinotecan Hydrochloride and Floxuridine liposome Injection
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
| Study group | Role | What they receive |
|---|---|---|
| LY010616(30 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
| LY010616(60 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
| LY010616(90 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
| LY010616(120 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
| LY010616(150 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
| LY010616(180 mg/m2) | Experimental | 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) Receives: Drug: LY010616 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) .
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
Secondary outcomes (8)
Area under the curve (AUC) of LY01616
Measured: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Maximum Concentration (Cmax) of LY01616
Measured: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Time of maximum concentration (Tmax) of LY01616
Measured: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Objective response rate (ORR)
Measured: up to 2 years
Disease control rate (DCR)
Measured: up to 2 years
Progression-free survival (PFS)
Measured: up to 2 years
Overall survival (OS);
Measured: up to 2 years
Duration of remission (DoR)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start22 Apr 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865925
- Sponsor's protocol ID
- LY01616/CT-CHN-101
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05865925
- Acronym / sponsor ID
- LY01616/CT-CHN-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY010616(30 mg/m2) | Experimental | Drug: LY01061630 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) |
| LY010616(60 mg/m2) | Experimental | Drug: LY01061660 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) |
| LY010616(90 mg/m2) | Experimental | Drug: LY01061690 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) |
| LY010616(120 mg/m2) | Experimental | Drug: LY010616120 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) |
| LY010616(150 mg/m2) | Experimental | Drug: LY010616150 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) |
| LY010616(180 mg/m2) | Experimental | Drug: LY010616180 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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℃);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY010616Also: Irinotecan Hydrochloride and Floxuridine liposome InjectionIV infusion was 90min (±5min), with an interval of 3 weeks between the first administration and the second administration, and once every 2 weeks thereafter | Drug | LY010616(120 mg/m2), LY010616(150 mg/m2), LY010616(180 mg/m2), LY010616(30 mg/m2), LY010616(60 mg/m2), LY010616(90 mg/m2) |
Primary outcome
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.
8 secondary outcomes
Area under the curve (AUC) of LY01616
Time frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Maximum Concentration (Cmax) of LY01616
Time frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Time of maximum concentration (Tmax) of LY01616
Time frame: up to cycle 6nd (cycle 1st is 21 days, the other cycles are 14 days)
Objective response rate (ORR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Overall survival (OS);
Time frame: up to 2 years
Duration of remission (DoR)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY010616 in people with Advanced Solid Tumors, 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 25 Apr 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.