Testing LPM6690176 in patients with advanced solid tumors

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 testing a new capsule treatment for people with advanced solid tumors who have run out of other options to see if it is safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Luye Pharma Group Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06240546 on ClinicalTrials.gov

What this trial studies

This phase 1, first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics of LPM6690176 capsules in patients with advanced solid tumors. The study will involve a dose-escalation and dose-expansion approach to assess preliminary anti-tumor activity. Participants will be closely monitored for any adverse effects and the effectiveness of the treatment. The study is designed for patients who have either failed standard therapies or have no available standard treatment options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced or metastatic unresectable solid tumors who have failed or are intolerant to standard therapies.

Not a fit: Patients with resectable tumors or those who have not yet undergone standard anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in evaluating new cancer therapies.

Eligibility criteria

Inclusion Criteria:

1. Able to provide a signed informed consent;
2. Age 18 \~ 75 years, male or female;
3. 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;
4. 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;
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
6. Life expectancy≥ 3 months;
7. 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);
8. 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.

Exclusion Criteria:

1. 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);
2. Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before signed informed consent decided by the investigator;
3. Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis;
4. 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;
   * 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).
5. 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;
6. Patients who may receive other systemic anti-tumor therapy or local radical therapy of target lesions/non-target lesions during the study;
7. History of drug abuse, drug addiction, or alcoholism;
8. Known hypersensitivity to any component of the study drug;
9. Patients who participated in other clinical trials and received treatment within 1 month;
10. Pregnant or lactating women;
11. Other conditions that may elevate the risk of the patient or interfere the study results decided by the investigator.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lin Shen, Doctor — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen, Doctor

Conditions Advanced Solid Tumor