This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate (ORR) by IRC according to RECIST 1.1
Time frame: 1-3 years
Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors
The assessment is based on the changes in AE, SAE, as well as safety and laboratory evaluation parameters.
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the IRC according to RECIST v1.1, the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Time frame: 1-3 years
Evaluate the PK of ES014
Evaluate based on the PK concentration of ES014
Time frame: 1-3 years
Evaluate the immunogenicity of ES014
By observing the generation process of ADA in ES014 for evaluation
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the DOR evaluated by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the DCR by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the FPS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
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Time frame: 1-3 years
The efficacy of ES014 in adult patients with desmoid tumors
Based on the OS by the researchers , the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.
Time frame: 1-3 years