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Advanced Solid TumorPhase 1NCT06240546

First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.

A Phase 1 study testing LPM6690176 in people with Advanced Solid Tumor, run by Luye Pharma Group 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
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Trial summary

This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176 capsules in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LPM6690176
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteChina
Study dates
12 Mar 2024to Feb 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide a signed informed consent;
  • Age 18 ~ 75 years, male or female;
  • Patients with histologically or cytologically confirmed advanced or metastatic unresectable solid tumors, who failed or intolerant to standard anti-tumor therapy or lack of standard therapy;
  • According to RECIST 1.1 criteria,
  • Dose escalation phase: patients with at least one non-measurable lesion;
  • Dose expansion phase: patients with at least one measurable lesion;
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  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
  • Life expectancy≥ 3 months;
  • Adequate bone marrow, liver, kidney, metabolism and coagulation function (blood transfusion, colony stimulating factors, albumin, and blood products are not allowed to use within 14 days before enrollment);
  • Negative pregnancy test within 7 days before first dose of study drug treatment in women of childbearing age. Female patients with childbearing potential were to use effective contraception during and for 6 months after the first dose of study drug treatment. Male patients (female partners with childbearing potential) should take effective contraceptive measures during study drug treatment and until 4 months after last dose of study drug administration.

Who cannot join

  • Patients who have not recovered from AEs caused by previous anti-tumor therapy to ≤ Grade 1 (assessed according to NCI-CTCAE 5.0 criteria, excluding alopecia and ≤ Grade 2 peripheral sensory neuropathy);
  • Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before signed informed consent decided by the investigator;
  • Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis;
  • Concomitant Diseases:
  • Any of the following diseases within 6 months before the first dose of study treatment: myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, and serious arrhythmia requiring treatment;
  • Patients who require long-term anticoagulant therapy or anti-platelet therapy or require long-term use of non-steroidal anti-inflammatory drugs;
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  • Patients with uncontrolled hypertension, hypertensive crisis or history of hypertensive encephalopathy;
  • Patients with increased risk of gastrointestinal ulcer or gastrointestinal bleeding tendency or gastrointestinal perforation tendency;
  • Patients with known active colitis within 8 weeks prior to screening, or diarrhea ≥4 times in 24 hours;
  • Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks before the first dose of study drug treatment;
  • HBsAg (+) and HBV DNA≥ 1×103 or HCV (+) or HIV (+);
  • Patients who have undergone major surgical procedures 4 weeks before the first dose of study drug treatment, or have severe injury, or requiring elective major surgery during the study, or have unhealed wounds, ulcers or fractures;
  • Exclusion criterion specific to dose expansion phase: patients who have any malignancy within 5 years before the first dose of study treatment except for the specific cancer under investigation in this study (cured carcinoma in situ of the cervix, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of breast ductal are eligible).
  • Prior Medications:
  • Patients who received anti-tumor therapy within 4 weeks before the first dose of study drug treatment;
  • Received LPM6690176 capsules or other PLK-1 inhibitors therapy before enrollment;
  • Received live attenuated vaccination within 4 weeks before signed informed consent;
  • Use of strong inducers or strong inhibitors of CYP3A4 within 2 weeks or 5 half-lives of the medication before the first dose of study drug treatment;
  • Use of medications mainly metabolized by CYP2B6 within 2 weeks or 5 half-lives (which takes longer time) of the medication before the first dose of study drug treatment;
  • Patients who may receive other systemic anti-tumor therapy or local radical therapy of target lesions/non-target lesions during the study;
  • History of drug abuse, drug addiction, or alcoholism;
  • Known hypersensitivity to any component of the study drug;
  • Patients who participated in other clinical trials and received treatment within 1 month;
  • Pregnant or lactating women;
  • Other conditions that may elevate the risk of the patient or interfere the study results decided by the investigator.

Trial locations and contacts

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

Lin Shen, Doctor contact

0086-10-88121122

doctorshenlin@sina.cn

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    Lin Shen, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LPM6690176 Capsules in Patients With Advanced Solid Tumors.

This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176 capsules in patients with advanced solid tumors.

Being tested
LPM6690176

What participants receive

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

  • LPM6690176Drug

    Also called LY01024

    Administered orally

Study groups in NCT06240546
Study groupRoleWhat they receive
2 mg/m2ExperimentalLPM6690176 capsules administered 2 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
4 mg/m2ExperimentalLPM6690176 capsules administered 4 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
8 mg/m2ExperimentalLPM6690176 capsules administered 8 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
16 mg/m2ExperimentalLPM6690176 capsules administered 16 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
24 mg/m2ExperimentalLPM6690176 capsules administered 24 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
36 mg/m2ExperimentalLPM6690176 capsules administered 36 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176
48 mg/m2ExperimentalLPM6690176 capsules administered 48 mg/m2 on day 1-5 (qd) every two weeks.
Receives: Drug: LPM6690176

What is being measured

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

  1. Number of dose-limiting toxicities (DLTs)

    Measured: From the first dose of study drug treatment through Cycle 1 (28 days)

  2. maximum tolerated dose (MTD) of LPM6690176

    Measured: From the first dose of study drug treatment through Cycle 1 (28 days)

Secondary outcomes (9)

  1. Overall response rate (ORR)

    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Approximately 2 years

  2. Duration of response (DOR)

    DOR is defined as the time from the first determination of an objective response (CR or PR) per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first, as assessed by the investigator

    Measured: Approximately 2 years

  3. isease control rate (DCR)

    DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by the investigato

    Measured: Approximately 2 years

  4. Progression-free survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug treatment to the date of the first documentation of progressive disease or death, whichever occurs first, as assessed by the investigator using RECIST v1.1.

    Measured: Approximately 2 years

  5. Overall survival (OS)

    OS is defined as the time from the date of the first dose of study drug treatment to the date of death (due to any reason) or documented last contact

    Measured: Approximately 3 years

  6. Maximum plasma concentration

    Maximum plasma concentration (Cmax) of LPM6690176 and its N-demethylated metabolite after a single dose and multiple dose

    Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).

  7. Time to maximum plasma concentration

    Time to maximum plasma concentration (Tmax) of LPM6690176 and its N-demethylated metabolite after a single dose and multiple dose.

    Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).

  8. Area under the plasma concentration-time curve

    Area under the concentration versus time curve from time zero to the last quantifiable time point (AUClast) of LPM6690176 and its N-demethylated metabolite after a single dose and multiple dose; Area under the concentration versus time curve from time 0 extrapolated to infinite time (AUCinf) of LPM6690176 and its N-demethylated metabolite after a single dose and multiple dose.

    Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).

  9. Elimination half-life

    Elimination half-life (t1/2) of LPM6690176 and its N-demethylated metabolite after a single dose and multiple dose.

    Measured: From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2 (28 days).

Timeline

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

  1. First posted5 Feb 2024
  2. Study start12 Mar 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06240546
Sponsor's protocol ID
LY01024/CT-CHN-101
Status last verified
Mar 2024
First submitted
26 Jan 2024
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LPM6690176 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 10 inclusion and 25 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 15 Mar 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 Lin Shen, Doctor (0086-10-88121122, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of dose-limiting toxicities (DLTs) (time frame: From the first dose of study drug treatment through Cycle 1 (28 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 NCT06240546.

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 15 Mar 2024.

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