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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054932
• Other study ID #: LK101-CT11
• Status: Recruiting
• Phase: Phase 1
• Start date: September 5, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: August 2023
• Source: Beijing Likang Life Science and Tech Co., Ltd.
• Contact: Zhipeng Wang, PhD
• Phone: 15902268943
• Email: wangzhipeng[@]likanglife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LK101 injection
LK101 administrated Q2W as the prime dose, and Q3W in the boost phase
• LK101 injection
LK101 administrated QW as the prime dose, and Q3W in the boost phase

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Likang Life Science and Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor immune microenvironment before and after treatment	CD8+T cell, PD-1, PD-L1, etc.	24 months
Primary	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
Primary	AE	incidence and severity of adverse events	Continuously throughout the study until 90 days after Termination of the treatment
Primary	irAE	incidence and severity of immune-related adverse events	Continuously throughout the study until 90 days after Termination of the treatment
Primary	SAE	incidence and severity of serious adverse events	Continuously throughout the study until 90 days after Termination of the treatment
Primary	RP2D	Recommended phase 2 immune procedure	21 days after the last prime dose
Secondary	immunogenicity	neoantigen specific T cell response by ELISpot measurement	24 months
Secondary	ORR	Objective Response Rate (ORR)according to mRECIST 1.1 standard	24 months
Secondary	DoR	Duration of remission	24 months
Secondary	DCR	Disease Control Rate	24 months
Secondary	TTR	Time to remission	24 months
Secondary	TTP	Time to progression	24 months
Secondary	PFS	Progression Free Survival	24 months
Secondary	OS	Overall Survival	24 months