Actively Recruiting
First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.
Led by Luye Pharma Group Ltd. · Updated on 2024-03-15
102
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide a signed informed consent
- Age 18 to 75 years, male or female
- Histologically or cytologically confirmed advanced or metastatic unresectable solid tumors, failed or intolerant to standard anti-tumor therapy or lacking standard therapy
- Dose escalation phase: at least one non-measurable lesion according to RECIST 1.1 criteria
- Dose expansion phase: at least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, kidney, metabolism and coagulation function; no blood transfusion, colony stimulating factors, albumin, or blood products within 14 days before enrollment
- Negative pregnancy test within 7 days before first dose for women of childbearing age
- Female patients with childbearing potential must use effective contraception during and for 6 months after first dose
- Male patients (whose female partners have childbearing potential) must use effective contraception during treatment and until 4 months after last dose
You will not qualify if you...
- Not recovered from adverse events of previous anti-tumor therapy to Grade 1 or less (excluding alopecia and Grade 2 or less peripheral sensory neuropathy)
- Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before consent
- Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis
- Cardiovascular or thrombotic conditions within 6 months before first dose: myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, serious arrhythmia requiring treatment
- Need for long-term anticoagulant, anti-platelet therapy, or long-term use of NSAIDs
- Uncontrolled hypertension, hypertensive crisis, or history of hypertensive encephalopathy
- Increased risk or history of gastrointestinal ulcer, bleeding, or perforation
- Active colitis within 8 weeks prior to screening or diarrhea four or more times in 24 hours
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks before first dose
- Positive for HBsAg with HBV DNA ≥ 1×10³, or positive for HCV or HIV
- Major surgery within 4 weeks before first dose, severe injury, planned elective major surgery during study, or unhealed wounds, ulcers, or fractures
- For dose expansion phase: any malignancy within 5 years before first dose except specified cured or superficial cancers
- Anti-tumor therapy within 4 weeks before first dose
- Prior use of LPM6690176 capsules or other PLK-1 inhibitors
- Live attenuated vaccination within 4 weeks before consent
- Use of strong CYP3A4 inducers or inhibitors within 2 weeks or 5 half-lives before first dose
- Use of medications mainly metabolized by CYP2B6 within 2 weeks or 5 half-lives before first dose
- Planned or ongoing systemic anti-tumor or local radical therapy during study
- History of drug abuse, addiction, or alcoholism
- Known hypersensitivity to any component of the study drug
- Participation in other clinical trials with treatment within 1 month
- Pregnant or lactating women
- Other conditions increasing risk or interfering with study as decided by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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