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

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: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LK101 injection; Drug: LK101 injection

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: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhipeng Wang, PhD; Phone Number: 86 15902268943; Email: wangzhipeng@likanglife.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Not yet recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Jie Wang, PhD, MD; Phone Number: 86 13910704669; Email: jiewang_hr@sina.com
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Guo, PhD, MD; Phone Number: 010 888121122; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Continuously throughout the study until 90 days after Termination of the treatment
AE	incidence and severity of adverse events	Continuously throughout the study until 90 days after Termination of the treatment
irAE	incidence and severity of immune-related adverse events	Continuously throughout the study until 90 days after Termination of the treatment
SAE	incidence and severity of serious adverse events	Continuously throughout the study until 90 days after Termination of the treatment
RP2D	Recommended phase 2 immune procedure	21 days after the last prime dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	24 months
DCR	Disease Control Rate	24 months
OS	Overall Survival	24 months
TTP	Time to progression	24 months
DoR	Duration of remission	24 months
TTR	Time to remission	24 months
immunogenicity	neoantigen specific T cell response by ELISpot measurement	24 months
ORR	Objective Response Rate (ORR)according to mRECIST 1.1 standard	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor immune microenvironment before and after treatment	CD8+T cell, PD-1, PD-L1, etc.	24 months

Collaborators and Investigators

• Sponsor: Beijing Likang Life Science and Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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