Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLuye Pharma Group Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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;

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • LPM6690176

    Drug

    Administered orally

Treatment groups

102 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: 2 mg/m2Experimental treatment 1 intervention
Group B: 4 mg/m2Experimental treatment 1 intervention
Group C: 8 mg/m2Experimental treatment 1 intervention
Group D: 16 mg/m2Experimental treatment 1 intervention
Group E: 24 mg/m2Experimental treatment 1 intervention
Group F: 36 mg/m2Experimental treatment 1 intervention
Group G: 48 mg/m2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of dose-limiting toxicities (DLTs)

Time frame
From the first dose of study drug treatment through Cycle 1 (28 days)
2

maximum tolerated dose (MTD) of LPM6690176

Time frame
From the first dose of study drug treatment through Cycle 1 (28 days)

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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.

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luye Pharma Group Ltd.

Lead sponsor

Source ClinicalTrials.gov
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