An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
allowing 10% dose error
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDLT
To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion
Time frame: within 28 days
TRAE
To treatment-related adverse events (TRAE) and severity
Time frame: up to 96 weeks
PFS
To evaluate the progression-free survival of IMC008 in patients with CLDN18.2 positive advanced solid tumor
Time frame: upto 96 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Time frame: upto 96 weeks
Tmax
Tmax of CAR-T cells in the blood.
Time frame: upto 96 weeks
Lymphocyte subsets
CAR-T cell lymphocyte subsets/phenotype, etc.
Time frame: upto 96 weeks
OS
To evaluate the overall survival of of IMC008 in patients with CLDN18.2 positive advanced solid tumor
Time frame: upto 96 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.