A Trial of SHR-4849 in Advanced Solid Tumors | NCT06443489

NCT06443489

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
SHR-4849	Experimental		Drug: SHR-4849

Name	Type	Description	Arm Group Labels	Other Names
SHR-4849	Drug	SHR-4849	SHR-4849

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period		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；		up to 24 months
MTD or MAD：after all subjects of dose escalation phase be enrolled，and all subjects complete at least one cycle of dosing observation.		up to 24 months
RP2D：after all subjects of dose escalation and dose expansion phase be enrolled，and all subjects complete at least one cycle of dosing observation.		up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
ORR： Objective Response Rate (ORR) as Assessed by investigators. The proportion of subjects whose best response was PR or CR according to RECIST1.1		up to 24 months
DCR：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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 advanced solid tumors
At least one measurable lesion was identified per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has a life expectancy of at least 3 months.
Adequate organ function
Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug

Exclusion Criteria:

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.
Subjects with clinically significant hemorrhage
Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
Subjects highly suspected of interstitial lung disease
Subjects with serious infection within 4 weeks prior to the first dose
Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
Subjects who received major surgery within 4 weeks prior to the first dose
Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
Known allergic to any component of SHR-4849 products
Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,