Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors

September 22, 2023 updated by: Beijing Likang Life Science and Tech Co., Ltd.

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

This is an open-labeled, single-center phase I study in patients with incurable advanced solid tumors, who failed with all previous standard therapy. The aim is to observe and evaluate the safety, tolerability, and immunogenicity of LK101 injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed to evaluate the safety, tolerability, and immunogenicity of the dose escalation of LK101. We used the traditional "3+3" dose escalation design, Subjects who have been pathologically diagnosed with advanced solid tumors and defined as failing all previous standard therapy. LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. The dose escalation will be conducted in a sequential manner, enrolled patients were initially placed in cohort 1, in which the priming phase is administered at 2-week intervals. And then followed the next cohort 2, where the priming phase is administered at 1-week intervals. Decisions with regard to dose escalation to the next dose level will be made jointly by the investigators and the sponsor. AE data was collected until the 21 days following the last prime dose. safety and immunogenicity will also be used to inform the final dose and schedule. A minimum of 6 patients will be treated at the MTD/RP2D.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2weeks-intervals prime dose procedure
LK101 will be administered in a prime-boost schedule, which is 4 priming vaccination as 2-weeks-intervals followed by 3 booster vaccinations
Drug: LK101 injection
LK101 administrated Q2W as the prime dose, and Q3W in the boost phase
Drug: LK101 injection
LK101 administrated QW as the prime dose, and Q3W in the boost phase
Experimental: 1weeks-intervals prime dose procedure
LK101 will be administered in a prime-boost schedule, which is 4 priming vaccination as 1-weeks-intervals followed by 3 booster vaccinations
Drug: LK101 injection
LK101 administrated Q2W as the prime dose, and Q3W in the boost phase
Drug: LK101 injection
LK101 administrated QW as the prime dose, and Q3W in the boost phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence of Dose limited toxicity(DLT),incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Clinically significant abnormal changes in laboratory tests and other tests.
Continuously throughout the study until 90 days after Termination of the treatment
AE
Time Frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of adverse events
Continuously throughout the study until 90 days after Termination of the treatment
irAE
Time Frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of immune-related adverse events
Continuously throughout the study until 90 days after Termination of the treatment
SAE
Time Frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of serious adverse events
Continuously throughout the study until 90 days after Termination of the treatment
RP2D
Time Frame: 21 days after the last prime dose
Recommended phase 2 immune procedure
21 days after the last prime dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 24 months
Progression Free Survival
24 months
DCR
Time Frame: 24 months
Disease Control Rate
24 months
OS
Time Frame: 24 months
Overall Survival
24 months
TTP
Time Frame: 24 months
Time to progression
24 months
DoR
Time Frame: 24 months
Duration of remission
24 months
TTR
Time Frame: 24 months
Time to remission
24 months
immunogenicity
Time Frame: 24 months
neoantigen specific T cell response by ELISpot measurement
24 months
ORR
Time Frame: 24 months
Objective Response Rate (ORR)according to mRECIST 1.1 standard
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tumor immune microenvironment before and after treatment
Time Frame: 24 months
CD8+T cell, PD-1, PD-L1, etc.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Likang Life Science and Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LK101-CT11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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