A Trial of SHR-4849 in Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06443489

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

80

Starts

2024-06-26

Expected to finish

2026-12-01

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,

Where it is running

• Jilin Cancer Hospital — Jilin City, Changchun, China (enrolling)

Full record on ClinicalTrials.gov

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