RecruitingPhase 1NCT06443489

A Trial of SHR-4849 in Advanced Solid Tumors

A Phase I ,Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Efficacy of SHR-4849 in Patients With Advanced Solid Tumors

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

80 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849 for Advanced Solid Tumors.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

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 Criteria17

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,