This is an open label, single-site, investigator-initiated trial designed to evaluate the safety, tolerability and preliminary efficacy of ABOR2014(IPM511) injection in relapsed/ refactory HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGIncidence and severity of adverse events (AE)
AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame: up to 12 months
Clinically significant abnormal changes in vital signs
Time frame: up to 12 months
Clinically significant abnormal changes in laboratory tests
Time frame: up to 12 months
Maximum Plasma Concentration [Cmax] of IPM511
Time frame: up to 12 months
Time of Maximum Plasma Concentration [Tmax] of IPM511
Time frame: up to 12 months
Half-time of Plasma Concentration [T1/2] of IPM511
Time frame: up to 12 months
Antigen-specific T-cell responses in peripheral blood
Detected by Tetramer or TCRseq or Enzyme-linked Immunospot Assay(ELISPOT)
Time frame: up to 12 months
Change of Circulating tumor DNA (ctDNA) status (every 6 weeks)
Time frame: up to 12 months
Objective Response Rate, ORR
ORR is Defined as the number of patients with a complete response (CR) or partial response(PR) .
Time frame: up to 12 months
Duration of Response, DoR
DoR is defined as time from first tumor response(partial or complete) until either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 12 months
Progress Free Survival, PFS
PFS is defined as time between the date of first dose of IPM511 and the date either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner).
Time frame: up to 12 months
Overall Survival, OS
OS is defined as time between the date of first dose of IPM511 and the date of death due to any cause.
Time frame: up to 12 months