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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
LK101 administrated Q2W as the prime dose, and Q3W in the boost phase
LK101 administrated QW as the prime dose, and Q3W in the boost phase
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDLT
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.
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
AE
incidence and severity of adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
irAE
incidence and severity of immune-related adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
SAE
incidence and severity of serious adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
RP2D
Recommended phase 2 immune procedure
Time frame: 21 days after the last prime dose
immunogenicity
neoantigen specific T cell response by ELISpot measurement
Time frame: 24 months
ORR
Objective Response Rate (ORR)according to mRECIST 1.1 standard
Time frame: 24 months
DoR
Duration of remission
Time frame: 24 months
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DCR
Disease Control Rate
Time frame: 24 months
TTR
Time to remission
Time frame: 24 months
TTP
Time to progression
Time frame: 24 months
PFS
Progression Free Survival
Time frame: 24 months
OS
Overall Survival
Time frame: 24 months