In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with QL1604 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
QL1604, IV infusion
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGORR
Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST)
Time frame: up to 2 years
ORR
Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST)
Time frame: up to 2 years
6-month PFS rate
6-month progression-free survival (PFS) rate
Time frame: the proportion of subjects who have time interval over 6 months between the first dose and disease progression or death
6-month OS rate
6-month overall survival rate
Time frame: from the date of first dose until the date of 6-month
PFS
Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS)
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
PFS
Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST)
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
OS
Overall survival
Time frame: from the date of first dose until the date of death from any cause, assessed up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DOR
Duration of response
Time frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier), assessed up to 2 years