The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGDLT:the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)
Time frame: up to 21 days
Incidence and severity of AE/SAE:According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)
Time frame: up to 24 months
Objective Response Rate (ORR) as Assessed by investigators(The second stage)
Time frame: up to 24 months
ORR(The first stage)
Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1
Time frame: up to 24 months
DoR(The first stage)
Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.
Time frame: up to 24 months
DCR(The first stage)
Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1
Time frame: up to 24 months
PFS(The first stage)
Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)
Time frame: up to 24 months
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OS(The first stage)
Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.
Time frame: up to 30 months
DoR(The second stage)
Duration of Response (DOR) as Assessed by investigators according to RECIST1.1, Defined as the period of time from the first documented tumor response to the first documented objective progression or death of any cause.
Time frame: up to 24 months
DCR(The second stage)
Disease Control Rate(DCR) as Assessed by investigators. the proportion of subjects whose best response was PR or CR or SD according to RECIST1.1
Time frame: up to 24 months
PFS(The second stage)
Progression-free Survival (PFS) as Assessed by investigators according to RECIST1.1. Defined as the time from the initiation of the first medication to tumor progression or death from any cause (whichever comes first)
Time frame: up to 24 months
OS(The second stage)
Overall Survival . Defined as the time from the initiation of the first medication to death from any cause.
Time frame: up to 30 months
Incidence and severity of AE/SAE:According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The second stage)
Time frame: up to 24 months