AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT06054932

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

A Phase 1 study testing LK101 injection in people with Advanced Solid Tumor, run by Beijing Likang Life Science and Tech Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LK101 injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesChina
Study dates
5 Sep 2023to 30 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Zhipeng Wang, PhD contact

15902268943 ext. 86

wangzhipeng@likanglife.com

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100021

    Jun Guo, PhD, MD, 888121122 ext. 010, guoj307@126.com

    Recruiting

  • Cancer hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Jie Wang, PhD, MD, 13910704669 ext. 86, jiewang_hr@sina.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
LK101 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LK101 injectionDrug

    LK101 administrated Q2W as the prime dose, and Q3W in the boost phase

  • LK101 injectionDrug

    LK101 administrated QW as the prime dose, and Q3W in the boost phase

Study groups in NCT06054932
Study groupRoleWhat they receive
2weeks-intervals prime dose procedureExperimentalLK101 will be administered in a prime-boost schedule, which is 4 priming vaccination as 2-weeks-intervals followed by 3 booster vaccinations
Receives: Drug: LK101 injection
1weeks-intervals prime dose procedureExperimentalLK101 will be administered in a prime-boost schedule, which is 4 priming vaccination as 1-weeks-intervals followed by 3 booster vaccinations
Receives: Drug: LK101 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    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.

    Measured: Continuously throughout the study until 90 days after Termination of the treatment

  2. AE

    incidence and severity of adverse events

    Measured: Continuously throughout the study until 90 days after Termination of the treatment

  3. irAE

    incidence and severity of immune-related adverse events

    Measured: Continuously throughout the study until 90 days after Termination of the treatment

  4. SAE

    incidence and severity of serious adverse events

    Measured: Continuously throughout the study until 90 days after Termination of the treatment

  5. RP2D

    Recommended phase 2 immune procedure

    Measured: 21 days after the last prime dose

Secondary outcomes (8)

  1. immunogenicity

    neoantigen specific T cell response by ELISpot measurement

    Measured: 24 months

  2. ORR

    Objective Response Rate (ORR)according to mRECIST 1.1 standard

    Measured: 24 months

  3. DoR

    Duration of remission

    Measured: 24 months

  4. DCR

    Disease Control Rate

    Measured: 24 months

  5. TTR

    Time to remission

    Measured: 24 months

  6. TTP

    Time to progression

    Measured: 24 months

  7. PFS

    Progression Free Survival

    Measured: 24 months

  8. OS

    Overall Survival

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start5 Sep 2023
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06054932
Sponsor's protocol ID
LK101-CT11
Status last verified
Aug 2023
First submitted
30 Aug 2023
Last updated
26 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LK101 injection in people with Advanced Solid Tumor, run by Beijing Likang Life Science and Tech Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhipeng Wang, PhD (15902268943 ext. 86, wangzhipeng@likanglife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Continuously throughout the study until 90 days after Termination of the treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06054932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in