Evaluating LK101 for patients with advanced solid tumors

A Phase I Study of LK101 Monotherapy in Participants With Advanced Solid Tumors to Evaluate the Safety, Tolerability, and Immunogenicity

This study is testing a new vaccine called LK101 to see if it is safe and helps people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Likang Life Science and Tech Co., Ltd. (industry)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT06054932 on ClinicalTrials.gov

What this trial studies

This open-label, single-center phase I study aims to assess the safety, tolerability, and immunogenicity of LK101 in patients with incurable advanced solid tumors who have not responded to standard therapies. The study employs a traditional '3+3' dose escalation design, where participants receive a series of priming and booster vaccinations of LK101. The dose escalation will be conducted sequentially, with decisions made collaboratively by investigators and the sponsor based on safety and immunogenicity data. A minimum of six patients will be treated at the maximum tolerated dose or recommended phase 2 dose.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that are unresponsive to standard treatments.

Not a fit: Patients who have received prior therapeutic tumor vaccines or have other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: While this approach is novel, similar studies evaluating immunogenicity in advanced solid tumors have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* signed informed consent.
* Age 18-75.
* life expectancy ≥3 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors, unresponsive to standard treatment or for whom no standard treatment is available or appropriate.
* The sequencing of the tumor was qualified.
* Subject must have measurable diseases as per RECIST v1.1 criteria.
* According to the investigator's judgment, venous vascular conditions can meet the needs of apheresis.
* Adequate bone marrow, renal, and hepatic at screening and at Baseline.

Exclusion Criteria:

* Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.).
* Diagnosis of malignant diseases other than study disease within 5 years before screening (except for malignant tumors that can be expected to recover after treatment).
* Patients received systemic antitumor treatment within 2 weeks before the apheresis, or receive research drugs or device therapy.
* Received radiotherapy within 4 weeks prior to screening.
* Toxicity caused by previous treatment did not recover to CTCAE (version 5.0) Grade 1 or below (except hair loss and peripheral neuropathy).
* Patients who have active brain metastases or cancerous meningitis.
* History of significant cardiovascular and cerebrovascular disease occurred in the 6 months prior to screening, Any of the following cardiac criteria:

  * Mean resting corrected QT interval (QTc) \> 470 ms;
  * Left ventricular ejection fraction (LVEF) ≤ 50%;
  * American New York heart association (NYHA) heart function ≥ 2 or higher;
  * serious arrhythmia;
  * poorly controlled hypertension;
  * other serious heart diseases;
  * Patients with interstitial pneumonia, except those inactive and do not require hormone therapy disease;
* Any of the following test results are positive: human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA and novel coronavirus nucleic acid.
* Active tuberculosis (TB) during screening.
* Treatment with systemic steroids or other immunosuppressive agents within 14 days prior to screening;
* Vaccination within 4 weeks prior to screening.
* Major injuries and/or surgery =\< 4 weeks prior to screening.
* Persons with a history of psychotropic substance abuse and inability to abstain or with a history of mental disorders.
* Pregnant or lactating women.
* Other conditions are regimented at the investigators' discretion.

Where this trial is running

Beijing, Beijing and 1 other locations

• Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)
• Cancer hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Zhipeng Wang, PhD

Conditions: Advanced Solid Tumor