About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has provided informed consent prior to initiation of any study-procedures
Age from 18 to 75 years old at the time of signing the informed consent
Histologically or cytologically confirmed solid tumors
At least one measurable lesion was identified per RECIST 1.1
Disqualifiers
Subjects with active central nervous system (CNS) metastasis.
Subjects with a history of malignant tumors within 5 years prior to the first dose
Subjects with uncontrolled cancer pain.
Subjects with severe cardiovascular disease.
Trial design
Single group
Treatments tested in this trial
SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
DrugSHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
Treatment groups
Trial outcomes
Primary outcomes
DLT:the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)
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)
Objective Response Rate (ORR) as Assessed by investigators(The second stage)
Secondary outcomes
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
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.
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
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)
Sponsors and contacts
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